OneTouch UltraminiRecalls & reported problems across all models
LifeScan Europe GmbH · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 558
- Deaths reported
- 0
- Injuries reported
- 437
- Recalls
- 0
We found 8 models of OneTouch Ultramini by LifeScan Europe GmbH in the FDA's device registry (GUDID). Together they are named in 558 adverse event reports in the FDA's MAUDE database, received between Nov 29, 2016 and Jan 10, 2024 — classified as 437 injuries, 121 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (211 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OneTouch Ultramini problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings211
- Incorrect Or Inadequate Test Results133
- Adverse Event Without Identified Device or Use Problem68
- Device Displays Incorrect Message46
- Device Handling Problem33
- Loss of Power33
- Device Alarm System10
- Battery Problem7
Patient problems
- Shaking/Tremors154
- Sweating133
- No Consequences Or Impact To Patient117
- Dizziness111
- Hypoglycemia37
- Fainting31
- Blurred Vision28
- Nausea28
OneTouch Ultramini models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OneTouch Ultramini 021-212SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER286 reports
- OneTouch Ultramini 021-924SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER173 reports
- OneTouch Ultramini 021-514SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER78 reports
- OneTouch Ultramini 021-913SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER9 reports
- OneTouch Ultramini 021-211SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER8 reports
- OneTouch Ultramini 021-422SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER2 reports
- OneTouch Ultramini 021-208SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1 report
- OneTouch Ultramini 021-911SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER1 report
Recent OneTouch Ultramini adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryJul 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRA EASY 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 REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 1 WEEK PRIOR TO CONTACTING LFS WHEN THEY OPENED A NEW VIAL OF STRIPS (EXACT DATE AND TIME NOT COMMUNICATED). THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES WITH A FIXED DOSE OF REGULAR INSULIN AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT A FEW DAYS PRIOR TO CONTACTING LFS (EXACT DATE AND TIME NOT COMMUNICATED), THEY DEVELOPED HYPOGLYCEMIC SYMPTOMS OF FEELING ¿HUNGRY AND SWEATY¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED THEY TESTED THEIR BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED AN ALLEGED INACCURATE HIGH RESULT OF ¿160 MG/DL.¿ DESPITE THE ELEVATED READING, THE PATIENT CLAIMED THEY ATE FOOD AS SELF-TREATMENT FOR THE SYMPTOMS. THE PATIENT INFORMED THE CCA THAT MEDICAL INTERVENTION WAS NOT REQUIRED AS GENERALLY THEY HAVE A TENDENCY OF HYPOGLYCEMIA. THE PATIE
Patient problems: Diaphoresis; Hypoglycemia; Increased Appetite
MAUDE report 15009252 ↗InjuryJul 13, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6) 2022, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS), ALLEGING THAT THEIR ONETOUCH ULTRA EASY 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 REPORTED THAT THE ALLEGED METER INACCURACY BEGAN 1 WEEK PRIOR TO CONTACTING LFS WHEN THEY OPENED A NEW VIAL OF STRIPS (EXACT DATE AND TIME NOT COMMUNICATED). THE PATIENT STATED THAT THEY MANAGE THEIR DIABETES WITH A FIXED DOSE OF REGULAR INSULIN AND DENIED MAKING ANY CHANGES TO THEIR USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED ISSUE. THE PATIENT REPORTED THAT A FEW DAYS PRIOR TO CONTACTING LFS (EXACT DATE AND TIME NOT COMMUNICATED), THEY DEVELOPED HYPOGLYCEMIC SYMPTOMS OF FEELING ¿HUNGRY AND SWEATY¿. IN RESPONSE TO THE SYMPTOMS, THE PATIENT CLAIMED THEY TESTED THEIR BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED AN ALLEGED INACCURATE HIGH RESULT OF ¿160 MG/DL.¿ DESPITE THE ELEVATED READING, THE PATIENT CLAIMED THEY ATE FOOD AS SELF-TREATMENT FOR THE SYMPTOMS. THE PATIENT INFORMED THE CCA THAT MEDICAL INTERVENTION WAS NOT REQUIRED AS GENERALLY THEY HAVE A TENDENCY OF HYPOGLYCEMIA. THE PATIE
Patient problems: Diaphoresis; Hypoglycemia; Increased Appetite
MAUDE report 15009216 ↗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 ↗
Other LifeScan Europe GmbH products
All LifeScan Europe GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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