OneTouch Ultramini 021-924Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00353885008136), received between Nov 29, 2016 and Jan 10, 2024 — classified as 153 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (53 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.

• InjuryJan 10, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA MINI METER WAS DISPLAYING AN ¿ERROR 5¿ MESSAGE. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ON ADDITIONAL INFORMATION OBTAINED AFTER CUSTOMER CARE (CC) REVIEWED THE CALL RECORDING. THE PATIENT ALLEGED THAT THE ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2023, AT AN UNSPECIFIED TIME. THE PATIENT DID NOT REPORT HOW HE MANAGES HIS DIABETES, NOR WHETHER HE MADE ANY CHANGES IN RESPONSE TO THE ALLEGED ISSUE. THE CCA NOTICED DURING THE CALL, BETWEEN 4:43 PM AND 5:11 PM, THAT THE PATIENT WAS NOT OKAY AND HE CLAIMED THAT HIS ¿HANDS WERE SHAKING¿. THE PATIENT STATED THAT HE CALLED HIS DOCTOR WHO ASKED HIM TO TEST, HOWEVER THE PATIENT WAS NOT ABLE TO DO SO DUE TO THE ALLEGED ISSUE. THE PATIENT DID NOT REPORT ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THE ISSUE WAS RESOLVED DURING TROUBLESHOOTING. THE CCA ESTABLISHED THAT THE ERROR MESSAGE WAS CAUSED BY THE PATIENT¿S TESTING TECHNIQUE. NO FURTHER ACTION WAS TAKEN. THIS COMPLAINT IS BEING

  Patient problems: Shaking/Tremors

  MAUDE report 18482117 ↗
• InjuryJan 10, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRA MINI METER WAS DISPLAYING AN ¿ERROR 5¿ MESSAGE. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL AND ON ADDITIONAL INFORMATION OBTAINED AFTER CUSTOMER CARE (CC) REVIEWED THE CALL RECORDING. THE PATIENT ALLEGED THAT THE ERROR MESSAGE BEGAN TO APPEAR ON (B)(6) 2023, AT AN UNSPECIFIED TIME. THE PATIENT DID NOT REPORT HOW HE MANAGES HIS DIABETES, NOR WHETHER HE MADE ANY CHANGES IN RESPONSE TO THE ALLEGED ISSUE. THE CCA NOTICED DURING THE CALL, BETWEEN 4:43 PM AND 5:11 PM, THAT THE PATIENT WAS NOT OKAY AND HE CLAIMED THAT HIS ¿HANDS WERE SHAKING¿. THE PATIENT STATED THAT HE CALLED HIS DOCTOR WHO ASKED HIM TO TEST, HOWEVER THE PATIENT WAS NOT ABLE TO DO SO DUE TO THE ALLEGED ISSUE. THE PATIENT DID NOT REPORT ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS NOT BEING USED FOR THE FIRST TIME AND THE ISSUE WAS RESOLVED DURING TROUBLESHOOTING. THE CCA ESTABLISHED THAT THE ERROR MESSAGE WAS CAUSED BY THE PATIENT¿S TESTING TECHNIQUE. NO FURTHER ACTION WAS TAKEN. THIS COMPLAINT IS BEING

  Patient problems: Shaking/Tremors

  MAUDE report 18482089 ↗
• InjuryOct 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2023, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED INACCURACY ISSUE BEGAN 1 WEEK PRIOR TO CONTACTING LFS. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿180 AND 60 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE REPORTER STATED THAT THE PATIENT MANAGES HIS DIABETES WITH PILLS AND SOMETIMES INSULIN IF THE PILLS DO NOT WORK. THE REPORTER DENIED THE PATIENT TOOK ANY ACTION IN REGARDS TO HIS NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THE PATIENT DEVELOPED SYMPTOM OF ¿SHAKING¿ AT AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE BEGAN AND SELF-TREATED WITH FOOD AND DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING AND THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRECTLY

  Patient problems: Shaking/Tremors

  MAUDE report 17992921 ↗
• InjuryOct 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON OCTOBER 17, 2023, A REPORTER FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED INACCURACY ISSUE BEGAN 1 WEEK PRIOR TO CONTACTING LFS. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿180 AND 60 MG/DL¿ WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE REPORTER STATED THAT THE PATIENT MANAGES HIS DIABETES WITH PILLS AND SOMETIMES INSULIN IF THE PILLS DO NOT WORK. THE REPORTER DENIED THE PATIENT TOOK ANY ACTION IN REGARDS TO HIS NORMAL DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. THE REPORTER CLAIMED THE PATIENT DEVELOPED SYMPTOM OF ¿SHAKING¿ AT AN UNSPECIFIED DATE/TIME AFTER THE ALLEGED ISSUE BEGAN AND SELF-TREATED WITH FOOD AND DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER, THE SAME APPROVED SAMPLE SITE WAS USED FOR TESTING AND THE CORRECT TESTING PROCESS WAS BEING FOLLOWED. THE CCA CONFIRMED THE TEST STRIP VIAL WAS INTACT AND THE TEST STRIPS HAD BEEN STORED CORRE

  Patient problems: Shaking/Tremors

  MAUDE report 17992915 ↗
• InjuryApr 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON APRIL 06, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (ACCU-CHEK). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2023, AT 12:00 AM WHEN THEY OBTAINED AN UNSPECIFIED BLOOD GLUCOSE READING WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN) AND INSULIN (NOVORAPID, TWICE DAILY ON A SELF-ADJUSTING DOSE ACCORDING TO BLOOD GLUCOSE READINGS). AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTED TAKING AN INCREASED DOSE OF 4 UNITS OF NOVORAPID INSULIN. THE PATIENT CLAIMED THAT 3 HOURS AFTER THE ALLEGED ISSUE BEGAN, THEY DEVELOPED SYMPTOMS OF FEELING ¿SWEATY AND SHAKY¿. THE PATIENT REPORTED BEING TREATED BY THEIR SPOUSE WITH A SUGARY DRINK. PRIOR TO RECEIVING TREATMENT, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿129 MG/DL¿ WITH THE SUBJECT METER AND ¿64 MG/DL¿ ON THE OTHER METER, PERFORMED LESS THAN 10 MINUTES APART. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER.

  Patient problems: Diaphoresis; Hypoglycemia; Shaking/Tremors

  MAUDE report 16719761 ↗
• InjuryApr 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON APRIL 06, 2023, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (ACCU-CHEK). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY BEGAN ON (B)(6) 2023, AT 12:00 AM WHEN THEY OBTAINED AN UNSPECIFIED BLOOD GLUCOSE READING WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH ORAL MEDICATION (METFORMIN) AND INSULIN (NOVORAPID, TWICE DAILY ON A SELF-ADJUSTING DOSE ACCORDING TO BLOOD GLUCOSE READINGS). AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT REPORTED TAKING AN INCREASED DOSE OF 4 UNITS OF NOVORAPID INSULIN. THE PATIENT CLAIMED THAT 3 HOURS AFTER THE ALLEGED ISSUE BEGAN, THEY DEVELOPED SYMPTOMS OF FEELING ¿SWEATY AND SHAKY¿. THE PATIENT REPORTED BEING TREATED BY THEIR SPOUSE WITH A SUGARY DRINK. PRIOR TO RECEIVING TREATMENT, THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE READINGS OF ¿129 MG/DL¿ WITH THE SUBJECT METER AND ¿64 MG/DL¿ ON THE OTHER METER, PERFORMED LESS THAN 10 MINUTES APART. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER.

  Patient problems: Diaphoresis; Hypoglycemia; Shaking/Tremors

  MAUDE report 16719751 ↗
• InjuryMar 10, 2023Device Handling Problem; Device Handling Problem

  ON (B)(6) 2023, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) BRAZIL BY EMAIL ALLEGING THAT HIS ONETOUCH ULTRA MINI METER READ INACCURATELY LOW COMPARED TO A LABORATORY TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE PATIENT¿S EMAIL AND ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2023, AT 07:00 AM. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿108 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH DIET AND EXERCISE AND CLAIMED THAT AT AN UNSPECIFIED TIME AFTER HE RECEIVED THE READING ON THE SUBJECT METER, HE STARTED FEELING ¿DIZZINESS AND NAUSEA¿ AND WENT TO THE HOSPITAL. THE PATIENT REPORTED THAT HE ¿FAINTED¿ AT THE HOSPITAL. THAT SAME DAY AT 09:00 AM, THE DOCTOR PERFORMED A LABORATORY TEST AND OBTAINED A READING OF ¿405 MG/DL¿. THE PATIENT STATED THAT AFTER THE LABORATORY TEST, HE WAS TREATED WITH AN UNSPECIFIED SERUM AT THE HOSPITAL. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLE. THE CCA EDUCATED THE PATIENT ON THE USE OF CONTROL SOLUTION. THE PATIENT WAS UNABLE

  Patient problems: Dizziness; Nausea; Syncope/Fainting

  MAUDE report 16526856 ↗
• InjuryMar 10, 2023Device Handling Problem; Device Handling Problem

  ON (B)(6) 2023, THE PATIENT/LAY USER CONTACTED LIFESCAN (LFS) BRAZIL BY EMAIL ALLEGING THAT HIS ONETOUCH ULTRA MINI METER READ INACCURATELY LOW COMPARED TO A LABORATORY TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE PATIENT¿S EMAIL AND ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW UP CALL WITH THE PATIENT. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2023, AT 07:00 AM. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿108 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH DIET AND EXERCISE AND CLAIMED THAT AT AN UNSPECIFIED TIME AFTER HE RECEIVED THE READING ON THE SUBJECT METER, HE STARTED FEELING ¿DIZZINESS AND NAUSEA¿ AND WENT TO THE HOSPITAL. THE PATIENT REPORTED THAT HE ¿FAINTED¿ AT THE HOSPITAL. THAT SAME DAY AT 09:00 AM, THE DOCTOR PERFORMED A LABORATORY TEST AND OBTAINED A READING OF ¿405 MG/DL¿. THE PATIENT STATED THAT AFTER THE LABORATORY TEST, HE WAS TREATED WITH AN UNSPECIFIED SERUM AT THE HOSPITAL. DURING TROUBLESHOOTING, THE CCA CONFIRMED THAT THE PATIENT HAD USED AN APPROVED SAMPLE SITE TO OBTAIN THE BLOOD SAMPLE. THE CCA EDUCATED THE PATIENT ON THE USE OF CONTROL SOLUTION. THE PATIENT WAS UNABLE

  Patient problems: Dizziness; Nausea; Syncope/Fainting

  MAUDE report 16526842 ↗
• InjuryNov 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (ULTRA MINI). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021 AT AROUND 4:00 PM. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿167 MG/DL¿ WITH THE SUBJECT METER AND ¿117 MG/DL¿ ON THE OTHER DEVICE, PERFORMED 1 MINUTE APART. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF LONG- AND FAST-ACTING INSULIN AND ORAL MEDICATION. THE REPORTER CLAIMED THAT 7-10 MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT ADMINISTERED A CORRECTION DOSE OF 6 UNITS OF FAST-ACTING INSULIN IN RESPONSE TO THE ¿167 MG/DL¿ READING. THE REPORTER STATED THAT AROUND 4:12 PM, THE PATIENT DEVELOPED SYMPTOMS OF FEELING ¿WEAK, BREATHLESS, PRESENTED PALE SKIN/FACE AND HAD DIZZY LEGS;¿ SYMPTOMS HE ASSOCIATED WITH HYPOGLYCEMIA. THE REPORTER CLAIMED THAT 5 MINUTES AFTER THE ONSET OF SYMPTOMS, THE PATIENT¿S FAMILY HELPED TREAT HIM WITH FOOD AND DRINK AND WITHIN MINUTES HE STARTED TO FEEL BETTE

  Patient problems: Dizziness; Dyspnea; Fatigue; Hypoglycemia; Pallor

  MAUDE report 12833259 ↗
• InjuryNov 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (ULTRA MINI). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021 AT AROUND 4:00 PM. THE REPORTER CLAIMED THE PATIENT OBTAINED BLOOD GLUCOSE READINGS OF ¿167 MG/DL¿ WITH THE SUBJECT METER AND ¿117 MG/DL¿ ON THE OTHER DEVICE, PERFORMED 1 MINUTE APART. THE PATIENT MANAGES HIS DIABETES WITH A COMBINATION OF LONG- AND FAST-ACTING INSULIN AND ORAL MEDICATION. THE REPORTER CLAIMED THAT 7-10 MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT ADMINISTERED A CORRECTION DOSE OF 6 UNITS OF FAST-ACTING INSULIN IN RESPONSE TO THE ¿167 MG/DL¿ READING. THE REPORTER STATED THAT AROUND 4:12 PM, THE PATIENT DEVELOPED SYMPTOMS OF FEELING ¿WEAK, BREATHLESS, PRESENTED PALE SKIN/FACE AND HAD DIZZY LEGS;¿ SYMPTOMS HE ASSOCIATED WITH HYPOGLYCEMIA. THE REPORTER CLAIMED THAT 5 MINUTES AFTER THE ONSET OF SYMPTOMS, THE PATIENT¿S FAMILY HELPED TREAT HIM WITH FOOD AND DRINK AND WITHIN MINUTES HE STARTED TO FEEL BETT

  Patient problems: Dizziness; Dyspnea; Fatigue; Hypoglycemia; Pallor

  MAUDE report 12833255 ↗
• InjuryNov 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE REPORTER OF THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER ALLEGED THAT THE INACCURACY ISSUE STARTED ON (B)(6) 2021, IN THE MORNING. THE REPORTER NOTICED THAT HIS SISTER WAS ¿FALLING ASLEEP¿ AND WAS ¿SEMICONSCIOUS¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT TESTED WITH THE SUBJECT METER AND OBTAINED A READING OF ¿81 MG/DL¿. THE REPORTER DID NOT SPECIFY HOW HIS SISTER MANAGES HER DIABETES AND DID NOT REPORT WHETHER SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ISSUE. THE REPORTER STATED THAT HE CALLED THE AMBULANCE, AND THE PATIENT WENT TO THE HOSPITAL WHERE THE HCP PERFORMED A BLOOD GLUCOSE TEST ON AN AMBULANCE METER AND RECEIVED A READING OF ¿37 MG/DL¿. THE PATIENT WAS TREATED WITH IV FLUIDS AND A ¿SUGAR TUBE¿. THE REPORTER CLAIMED THAT HIS SISTER STAYED IN THE HOSPITAL FOR 7 HOURS AND IS NOW FEELING OK. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA NOTED THAT THE PATI

  Patient problems: Extreme Exhaustion

  MAUDE report 12756317 ↗
• InjuryNov 7, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE REPORTER OF THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THEIR ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE REPORTER ALLEGED THAT THE INACCURACY ISSUE STARTED ON (B)(6) 2021, IN THE MORNING. THE REPORTER NOTICED THAT HIS SISTER WAS ¿FALLING ASLEEP¿ AND WAS ¿SEMICONSCIOUS¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT TESTED WITH THE SUBJECT METER AND OBTAINED A READING OF ¿81 MG/DL¿. THE REPORTER DID NOT SPECIFY HOW HIS SISTER MANAGES HER DIABETES AND DID NOT REPORT WHETHER SHE MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN IN RESPONSE TO THE ISSUE. THE REPORTER STATED THAT HE CALLED THE AMBULANCE, AND THE PATIENT WENT TO THE HOSPITAL WHERE THE HCP PERFORMED A BLOOD GLUCOSE TEST ON AN AMBULANCE METER AND RECEIVED A READING OF ¿37 MG/DL¿. THE PATIENT WAS TREATED WITH IV FLUIDS AND A ¿SUGAR TUBE¿. THE REPORTER CLAIMED THAT HIS SISTER STAYED IN THE HOSPITAL FOR 7 HOURS AND IS NOW FEELING OK. DURING TROUBLESHOOTING, THE CCA ESTABLISHED THAT THE PATIENT WAS FOLLOWING THE CORRECT TESTING PROCEDURE. THE CCA NOTED THAT THE PATI

  Patient problems: Extreme Exhaustion

  MAUDE report 12756312 ↗
• InjuryAug 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO A HOSPITAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON THE MORNING OF (B)(6) 2021, THE PATIENT BEGAN TO DEVELOP SYMPTOMS OF ¿DEHYDRATION AND DIARRHOEA.¿ IN RESPONSE TO THE SYMPTOMS, THE REPORTER CLAIMED THE PATIENT TOOK HER USUAL DOSE OF DIABETES MEDICATION (1 PILL OF DIAMICRON) BUT CONTINUED TO FEEL SYMPTOMATIC; SYMPTOMS OF ¿LACK OF SPEECH, TREMBLING, CLOUDY VISION, LOW BLOOD GLUCOSE¿ WERE REPORTED. THE REPORTER CLAIMED THE PATIENT WAS TREATED WITH LIQUID DEXTROSE AT 3:00 PM AFTER OBTAINING BLOOD GLUCOSE READINGS OF ¿80 MG/DL¿ THEN ¿50 MG/DL¿ WITH THE SUBJECT METER. HOWEVER, THE PATIENT CONTINUED TO FEEL BAD AND WAS TAKEN TO HOSPITAL WHERE SHE OBTAINED A BLOOD GLUCOSE READING OF ¿340 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿240 MG/DL¿ ON THE HOSPITAL METER. THE READINGS WERE TAKEN AT THE SAME TIME AS EACH OTHER. THE REPORTER CLAIMED THE PATIENT WAS TREATED IN HOSPITAL WITH

  Patient problems: Blurred Vision; Dehydration; Diarrhea; Dysphasia; Hypoglycemia; Shaking/Tremors

  MAUDE report 12334494 ↗
• InjuryAug 17, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, A REPORTER FOR THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO A HOSPITAL METER. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER CARE AGENT (CCA) DURING A FOLLOW-UP CALL WITH THE REPORTER. THE REPORTER STATED THAT ON THE MORNING OF (B)(6) 2021, THE PATIENT BEGAN TO DEVELOP SYMPTOMS OF ¿DEHYDRATION AND DIARRHOEA.¿ IN RESPONSE TO THE SYMPTOMS, THE REPORTER CLAIMED THE PATIENT TOOK HER USUAL DOSE OF DIABETES MEDICATION (1 PILL OF DIAMICRON) BUT CONTINUED TO FEEL SYMPTOMATIC; SYMPTOMS OF ¿LACK OF SPEECH, TREMBLING, CLOUDY VISION, LOW BLOOD GLUCOSE¿ WERE REPORTED. THE REPORTER CLAIMED THE PATIENT WAS TREATED WITH LIQUID DEXTROSE AT 3:00 PM AFTER OBTAINING BLOOD GLUCOSE READINGS OF ¿80 MG/DL¿ THEN ¿50 MG/DL¿ WITH THE SUBJECT METER. HOWEVER, THE PATIENT CONTINUED TO FEEL BAD AND WAS TAKEN TO HOSPITAL WHERE SHE OBTAINED A BLOOD GLUCOSE READING OF ¿340 MG/DL¿ WITH THE SUBJECT METER COMPARED TO ¿240 MG/DL¿ ON THE HOSPITAL METER. THE READINGS WERE TAKEN AT THE SAME TIME AS EACH OTHER. THE REPORTER CLAIMED THE PATIENT WAS TREATED IN HOSPITAL WITH

  Patient problems: Blurred Vision; Dehydration; Diarrhea; Dysphasia; Hypoglycemia; Shaking/Tremors

  MAUDE report 12334486 ↗
• InjuryJul 2, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE REPORTER CONTACTED LIFESCAN (LFS) PERU, ALLEGING THAT HER GRANDMOTHER¿S ONETOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL, AFTER REVIEW OF THE CALL AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2021. THE REPORTER CLAIMED THAT THE ALLEGED ISSUE BEGAN AT 9 A.M., ON (B)(6) 2021. THE REPORTER ADVISED THAT HER GRANDMOTHER FELT ¿DIZZY¿ AND OBTAINED A BLOOD GLUCOSE READING OF ¿221 MG/DL¿ ON THE SUBJECT METER AFTER SHE DEVELOPED THE SYMPTOM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE AND DOSE UNSPECIFIED) AND THE REPORTER STATED THAT IN RESPONSE TO THE ALLEGED ISSUE, THEY CALLED THE DOCTOR. THE REPORTER MENTIONED THAT HER GRANDMOTHER ALSO ADMINISTERED 18 MG OF INSULIN AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED. APPROXIMATELY 12 HOURS LATER, AROUND 10 P.M. THAT SAME DAY, THE DOCTOR CAME BY AND OBTAINED A BLOOD GLUCOSE READING OF ¿61 MG/DL¿ ON A HOSPITAL METER. DURING THE FOLLOW-UP CALL, THE PATIENT CONFIRMED THAT THE DOCTOR TREATED HER WITH DEXTROSE AND TWO

  Patient problems: Vertigo

  MAUDE report 12112569 ↗
• InjuryJul 2, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE REPORTER CONTACTED LIFESCAN (LFS) PERU, ALLEGING THAT HER GRANDMOTHER¿S ONETOUCH ULTRA MINI METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL, AFTER REVIEW OF THE CALL AND ON ADDITIONAL INFORMATION OBTAINED DURING A FOLLOW-UP CALL WITH THE PATIENT ON (B)(6) 2021. THE REPORTER CLAIMED THAT THE ALLEGED ISSUE BEGAN AT 9 A.M., ON (B)(6) 2021. THE REPORTER ADVISED THAT HER GRANDMOTHER FELT ¿DIZZY¿ AND OBTAINED A BLOOD GLUCOSE READING OF ¿221 MG/DL¿ ON THE SUBJECT METER AFTER SHE DEVELOPED THE SYMPTOM. THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE AND DOSE UNSPECIFIED) AND THE REPORTER STATED THAT IN RESPONSE TO THE ALLEGED ISSUE, THEY CALLED THE DOCTOR. THE REPORTER MENTIONED THAT HER GRANDMOTHER ALSO ADMINISTERED 18 MG OF INSULIN AT AN UNSPECIFIED TIME AFTER THE ALLEGED ISSUE OCCURRED. APPROXIMATELY 12 HOURS LATER, AROUND 10 P.M. THAT SAME DAY, THE DOCTOR CAME BY AND OBTAINED A BLOOD GLUCOSE READING OF ¿61 MG/DL¿ ON A HOSPITAL METER. DURING THE FOLLOW-UP CALL, THE PATIENT CONFIRMED THAT THE DOCTOR TREATED HER WITH DEXTROSE AND TWO

  Patient problems: Vertigo

  MAUDE report 12112568 ↗
• InjuryMay 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT UNKNOWN TIME BEFORE (B)(6) 2021. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿200 MG/DL¿ WITH THE SUBJECT DEVICE WHICH HE FELT WAS INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE PATIENT MANAGES HIS DIABETES WITH SELF-ADJUSTED INSULIN ¿NOVOLOG AND LANTUS¿ (DOSE UNKNOWN). THE PATIENT REPORTED THAT HE TOOK AN UNSPECIFIED SHOT OF INSULIN IN RESPONSE TO THE ALLEGED RESULT. THE PATIENT REPORTED THAT AT 1:30PM ON (B)(6) 2021, AFTER OBTAINING THE ALLEGED INACCURATELY HIGH BLOOD GLUCOSE READING, HE DEVELOPED SYMPTOMS OF ¿LIGHTHEADED, DIZZY AND ABOUT TO PASS OUT¿. THE PATIENT STATED THAT HE SELF-TREATED WITH FOOD AND DRINK ¿ORANGE JUICE¿. HE RETESTED HIS BLOOD AND OBTAINED A BLOOD GLUCOSE RESULT OF 60MG/DL ON ANOTHER, UNKNOWN DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT T

  Patient problems: Dizziness

  MAUDE report 11780806 ↗
• InjuryMay 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THEIR ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED THAT ON ONE OCCASION 3 WEEKS PRIOR TO CONTACTING LFS (DATE NOT REPORTED), THEY OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿400 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INTERMEDIATE AND FAST-ACTING INSULIN ON A SELF-ADJUSTING DOSE. IN RESPONSE TO THE ELEVATED READING, THE PATIENT REPORTED ADMINISTERING AN UNSPECIFIED DOSE OF INSULIN. AFTER THE INSULIN WAS ADMINISTERED, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOMS OF ¿DIZZINESS¿, ¿WEAKNESS¿ AND THEIR ¿VISION WAS AFFECTED.¿ THE PATIENT CLAIMED THEY CONSUMED FOOD/DRINK AS TREATMENT. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. R

  Patient problems: Dizziness; Fatigue; Visual Impairment

  MAUDE report 11773698 ↗
• InjuryMay 4, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THEIR ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO THEIR FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT WAS UNABLE TO RECALL WHEN THE ALLEGED METER INACCURACY BEGAN. THE PATIENT REPORTED THAT ON ONE OCCASION 3 WEEKS PRIOR TO CONTACTING LFS (DATE NOT REPORTED), THEY OBTAINED AN ALLEGED INACCURATE HIGH BLOOD GLUCOSE READING OF ¿400 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES THEIR DIABETES WITH INTERMEDIATE AND FAST-ACTING INSULIN ON A SELF-ADJUSTING DOSE. IN RESPONSE TO THE ELEVATED READING, THE PATIENT REPORTED ADMINISTERING AN UNSPECIFIED DOSE OF INSULIN. AFTER THE INSULIN WAS ADMINISTERED, THE PATIENT CLAIMED THEY DEVELOPED SYMPTOMS OF ¿DIZZINESS¿, ¿WEAKNESS¿ AND THEIR ¿VISION WAS AFFECTED.¿ THE PATIENT CLAIMED THEY CONSUMED FOOD/DRINK AS TREATMENT. NO OTHER DEVICE WAS USED FOR TESTING. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. R

  Patient problems: Dizziness; Fatigue; Visual Impairment

  MAUDE report 11773697 ↗
• InjuryApr 23, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2021, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER CARE AGENT (CCA) DURING THE INITIAL CALL. THE PATIENT REPORTED THAT THE ALLEGED INACCURACY ISSUE BEGAN AT UNKNOWN TIME BEFORE (B)(6) 2021. THE PATIENT CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿200 MG/DL¿ WITH THE SUBJECT DEVICE WHICH HE FELT WAS INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE PATIENT MANAGES HIS DIABETES WITH SELF-ADJUSTED INSULIN ¿NOVOLOG AND LANTUS¿ (DOSE UNKNOWN). THE PATIENT REPORTED THAT HE TOOK AN UNSPECIFIED SHOT OF INSULIN IN RESPONSE TO THE ALLEGED RESULT. THE PATIENT REPORTED THAT AT 1:30PM ON (B)(6) 2021, AFTER OBTAINING THE ALLEGED INACCURATELY HIGH BLOOD GLUCOSE READING, HE DEVELOPED SYMPTOMS OF ¿LIGHTHEADED, DIZZY AND ABOUT TO PASS OUT¿. THE PATIENT STATED THAT HE SELF-TREATED WITH FOOD AND DRINK ¿ORANGE JUICE¿. HE RETESTED HIS BLOOD AND OBTAINED A BLOOD GLUCOSE RESULT OF 60MG/DL ON ANOTHER, UNKNOWN DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THAT T

  Patient problems: Dizziness

  MAUDE report 11713067 ↗
• InjuryMar 29, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE LAY-USER/PATIENT¿S SON CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (EMERGENCY MEDICAL SERVICES METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER WAS UNABLE TO BE CONTACTED FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6), 2021. THE REPORTER CLAIMED THE PATIENT WAS ¿HYPOGLYCEMIC; ALMOST IN A COMA AND WHEN THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE SUBJECT METER A READING OF 79 MG/L WAS OBTAINED. THE EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED FOR ASSISTANCE. THE REPORTER CLAIMED THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE EMS METER AND A READING OF 39 MG/DL WAS OBTAINED. THE TIME DIFFERENCE BETWEEN THE READINGS WAS NOT PROVIDED. THE REPORTER CLAIMED THE PATIENT WAS TREATED BY EMS WITH INTRAVENOUS (IV) GLUCOSE. NO HOSPITALIZATION WAS REPORTED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE TEST STRIPS ASSOCIATED WITH THE COMPLAINT HAD EXPIRED BY SEVERAL YEARS. REPLACE

  Patient problems: Hypoglycemia

  MAUDE report 11586663 ↗
• InjuryMar 29, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE LAY-USER PATIENT¿S SON CONTACTED (B)(4). ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (EMERGENCY MEDICAL SERVICES METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER WAS UNABLE TO BE CONTACTED FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6), 2021. THE REPORTER CLAIMED THE PATIENT WAS ¿HYPOGLYCEMIC; ALMOST IN A COMA¿ AND WHEN THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE SUBJECT METER A READING OF 79 MG/L WAS OBTAINED. THE EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED FOR ASSISTANCE. THE REPORTER CLAIMED THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE EMS METER AND A READING OF 39 MG/DL WAS OBTAINED. THE TIME DIFFERENCE BETWEEN THE READINGS WAS NOT PROVIDED. THE REPORTER CLAIMED THE PATIENT WAS TREATED BY EMS WITH INTRAVENOUS (IV) GLUCOSE. NO HOSPITALIZATION WAS REPORTED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE TEST STRIPS ASSOCIATED WITH THE COMPLAINT HAD EXPIRED BY SEVERAL YEARS. REPLACEMENT PRODUCT W

  Patient problems: Hypoglycemia

  MAUDE report 11586662 ↗
• InjuryMar 29, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE LAY-USER/PATIENT¿S SON CONTACTED LIFESCAN (LFS) (B)(6), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (EMERGENCY MEDICAL SERVICES METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER WAS UNABLE TO BE CONTACTED FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021. THE REPORTER CLAIMED THE PATIENT WAS ¿HYPOGLYCEMIC; ALMOST IN A COMA¿ AND WHEN THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE SUBJECT METER A READING OF ¿79 MG/L¿ WAS OBTAINED. THE EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED FOR ASSISTANCE. THE REPORTER CLAIMED THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE EMS METER AND A READING OF ¿39 MG/DL¿ WAS OBTAINED. THE TIME DIFFERENCE BETWEEN THE READINGS WAS NOT PROVIDED. THE REPORTER CLAIMED THE PATIENT WAS TREATED BY EMS WITH INTRAVENOUS (IV) GLUCOSE. NO HOSPITALIZATION WAS REPORTED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE TEST STRIPS ASSOCIATED WITH THE COMPLAINT HAD EXPIRED BY SEVERAL YEARS. REP

  Patient problems: Hypoglycemia

  MAUDE report 11586661 ↗
• InjuryMar 29, 2021Device Handling Problem; Device Handling Problem

  ON (B)(6) 2021, THE LAY-USER/PATIENT¿S SON CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE PATIENT¿S ONETOUCH ULTRA MINI METER READ INACCURATELY HIGH COMPARED TO ANOTHER METER (EMERGENCY MEDICAL SERVICES METER). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION, SINCE THE REPORTER WAS UNABLE TO BE CONTACTED FOR ADDITIONAL INFORMATION. THE REPORTER STATED THAT THE ALLEGED METER INACCURACY OCCURRED ON (B)(6) 2021. THE REPORTER CLAIMED THE PATIENT WAS ¿HYPOGLYCEMIC; ALMOST IN A COMA¿ AND WHEN THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE SUBJECT METER A READING OF ¿79 MG/L¿ WAS OBTAINED. THE EMERGENCY MEDICAL SERVICES (EMS) WERE CONTACTED FOR ASSISTANCE. THE REPORTER CLAIMED THE PATIENT¿S BLOOD GLUCOSE WAS MEASURED WITH THE EMS METER AND A READING OF ¿39 MG/DL¿ WAS OBTAINED. THE TIME DIFFERENCE BETWEEN THE READINGS WAS NOT PROVIDED. THE REPORTER CLAIMED THE PATIENT WAS TREATED BY EMS WITH INTRAVENOUS (IV) GLUCOSE. NO HOSPITALIZATION WAS REPORTED. AT THE TIME OF TROUBLESHOOTING, THE CCA CONFIRMED THE UNIT OF MEASURE WAS SET CORRECTLY ON THE SUBJECT METER. THE CCA NOTED THE TEST STRIPS ASSOCIATED WITH THE COMPLAINT HAD EXPIRED BY SEVERAL YEARS. REP

  Patient problems: Hypoglycemia

  MAUDE report 11586660 ↗
• InjuryDec 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6) 2020, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HIS ONETOUCH ULTRAMINI METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE AGENT (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED METER INACCURACY OCCURRED AROUND (B)(6) 2020. THE PATIENT REPORTED OBTAINING ALLEGED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿130, 352, 401 AND 481 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT STATED THAT HE MANAGES HIS DIABETES WITH UNSPECIFIED INSULIN ON A SELF-ADJUSTING DOSE. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT REPORTED ADMINISTERING 12 UNITS OF INSULIN ON (B)(6) 2020 THEN ¿FAINTED.¿ THE PATIENT CLAIMED HE WAS TAKEN TO HOSPITAL WHERE HIS BLOOD GLUCOSE TESTED ¿40 MG/DL¿ (DEVICE NOT SPECIFIED). THE PATIENT CLAIMED HE WAS TREATED IN HOSPITAL WITH GLUCOSE AND WAS ADVISED TO ADMINISTER INSULIN ACCORDING TO MEDICAL RECOMMENDATION. THE PATIENT REPORTED THAT PRIOR TO BEING RELEASED FROM HOSPITAL, HIS BLOOD GLUCOSE TESTED ¿123 MG/DL¿ (DEVICE NOT SPECIFIED). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED ME

  Patient problems: Hypoglycemia; Syncope/Fainting

  MAUDE report 11011628 ↗