McKesson 06-RE4051-43Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 20612479197231), received between Nov 28, 2016 and Mar 22, 2021 — classified as 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “High Test Results” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 6, 2026Class IOpen, Classified

   The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

   Z-1545-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryMar 22, 2021Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. CUSTOMER HAS HAD THE TRUEMETRIX METER FOR OVER A YEAR HAD THE BATTERY HAS NEVER BEEN CHANGED. DURING THE CALL, THE TRUEMETRIX METER DID NOT POWER ON USING THE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED. CUSTOMER'S TEST STRIPS WERE EXPIRED: MANUFACTURER¿S EXPIRATION DATE IS 09/19/2017. AT THE TIME OF THE CALL THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. WIFE REPORTED THAT IN (B)(6) 2020 CUSTOMER HAD BEEN HOSPITALIZED AND THE DIAGNOSIS HAD BEEN ATRIAL FIBRILLATION AND HYPOGLYCEMIA. WIFE ALSO STATED THAT CUSTOMER DOES USE ANOTHER BRAND METER AND COULD NOT CONFIRM IF CUSTOMER WAS USING THE TRUEMETRIX METER AT THE TIME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Atrial Fibrillation; Hypoglycemia

  MAUDE report 11543459 ↗
• MalfunctionMar 17, 2020High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. AT THE TIME OF THE CALL, THE CUSTOMER STATED THAT HE WAS THIRSTY, HAD BLURRY VISION, AND WAS HUNGRY EVEN THOUGH HE HAD JUST EATEN. CUSTOMER WAS ADVISED TO SEEK MEDICAL ATTENTION; CUSTOMER DID NOT CONFIRM THAT HE WOULD GO TO THE HOSPITAL AT THE TIME OF CALL. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Blurred Vision; Polydipsia

  MAUDE report 9842040 ↗
• MalfunctionSep 9, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING LIGHTHEADED AND NAUSEOUS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS OR REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 321MG/DL NON-FASTING USING. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/29/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Nausea

  MAUDE report 8977840 ↗
• MalfunctionMar 28, 2019High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED A COMPLAINT FOR ERROR AND HI DISPLAY. THE HOSPICE NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CALLER DID REPORT SYMPTOM OF PATIENT BEING UNCONSCIOUS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED HI DISPLAY USING THE METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Loss of consciousness

  MAUDE report 8461617 ↗
• MalfunctionMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NURSE IS CALLING ON BEHALF OF THE CUSTOMER. NURSE CALLING REQUESTING THE OWNER'S MANUAL FOR THE METER. NURSE STATES THAT THE PATIENT CAME IN TO THE OFFICE AND THE ATTEMPTED TO RUN HER BLOOD SUGAR AND THE METER GAVE THE E-5 ERROR. NURSE WAS NOT SURE WHAT THE ERROR MESSAGE MEANT SO THEY WENT ONLINE AND LOOK UP WHAT THE ERROR MEANT. THE PATIENT WAS NOT FEELING WELL SO THEY SEND HE TO THE HOSPITAL. NO SYMPTOMS AND TREATMENT DETAIL PROVIDED BY THE NURSE. CUSTOMER BLOOD SUGAR AT THE HOSPITAL WAS 900MG/DL. NURSE STATES THAT THE PATIENT IS FEELING FINE NOW, AND SHE DID NOT WANT TO PROVIDE THE PATIENT INFORMATION. NURSE STATES THAT OBVIOUS THE METER IS DOING ITS JOB AND IS WORKING FINE. NURSE JUST NEED THE OWNER'S MANUAL. THE CUSTOMER IS NOW FEELING FINE (NO SYMPTOMS AND NO FURTHER MEDICAL ATTENTION IS REQUIRED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS UNKNOWN AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia; No Information

  MAUDE report 8392006 ↗
• MalfunctionFeb 21, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 169, 168, 149, 240 AND 170 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 140 MG/DL. CUSTOMER STATED THE HIGH BLOOD RESULTS STARTED ABOUT 1-2 WEEKS AGO. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2019, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE CLOSET. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/23/2019 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8357559 ↗
• MalfunctionFeb 5, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DOCTOR'S OFFICE IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING ILL WITH SYMPTOMS OF FREQUENT URINATION, BLURRY VISION, FEELING WEAK/TIRED AND OFTEN HUNGRY. CUSTOMER HAD GONE TO THE DIABETIC EDUCATORS FOR ASSISTANCE WITH THE METER AND THEY HAD RECEIVED HIGH READINGS. DOCTOR'S OFFICE CALLED IN TO REQUEST CONTROL SOLUTIONS TO TEST THE METER. CUSTOMER DID NOT INITIALLY GO TO HER DIABETIC EDUCATOR DUE TO DIABETIC SYMPTOMS OR BECAUSE OF HIGH RESULTS. DOCTOR'S OFFICE REALIZED THAT SHE HAD SYMPTOMS AND THAT THE RESULTS WERE ELEVATED WHEN SHE ARRIVED AT THE OFFICE. CUSTOMER COULD NOT CONTINUE WITH THE TROUBLESHOOTING AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Blurred Vision; Fatigue; Weakness

  MAUDE report 8305687 ↗
• MalfunctionDec 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE IS 11/12/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED THAT METER IS READING HIGH. CUSTOMER IS STORING STRIPS PROPERLY AND CLAIMS TO BE USING THE CORRECT TESTING TECHNIQUE. CUSTOMER DOES NOT HAVE ANY CONTROL SOLUTION TO TEST METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8135647 ↗
• MalfunctionNov 13, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 187, 206, 196, 168 AND 169 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 140 MG/DL. CUSTOMER STATED SHE NOTICED AN INCREASE IN THE RESULTS FOR THE PAST FEW MONTHS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018 BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:187 MG/DL DATE:(B)(6) 2018 TIME:1:00 AM FASTING. RESULT 2:206 MG/DL DATE:(B)(6) 2018 TIME:5:32 AM FASTING. RESULT 3:196 MG/DL DATE:(B)(6) 2018 TIME:1:00 AM FASTING. RESULT 4:168 MG/DL DATE:(B)(6) 2018 TIME:5:14 AM FASTING. RESULT 5:169 MG/DL DATE:(B)(6) 2018 TIME:5:27 AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8065772 ↗
• MalfunctionAug 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/13/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7798604 ↗
• MalfunctionJul 25, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 70, 141 AND 283 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 150 MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING LETHARGIC AND SWEATY. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE DINING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 9/15/2019 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). ON (B)(6) 2018 CUSTOMER TOOK HIS BLOOD SUGAR AND IT WAS 141 MG/DL. HE THEN TOOK HIS 22 UNITS OF INSULIN AND STARTED TO EAT. WHILE EATING HE HAD A LOW BLOOD GLUCOSE REACTION. THE CUSTOMER WAS SWEATING, AND WIFE SAY HE WAS TALKING THINGS THAT WAS NOT MAKING SENSE. SHE GAVE HIM 2 GLASSES OF ORANGE JUICE AND CALLED 911. THE AMBULANCE WAS THERE WITHIN 10 MINUTES AND TOOK HIS BLOOD SUGAR. IT WAS 47 MG/DL. THEY GAVE HIM HALF BAG

  Patient problems: Lethargy; Sweating

  MAUDE report 7720502 ↗
• MalfunctionJul 13, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-0 ERROR: INVALID HEMATOCRIT. FRIEND IS CALLING ON BEHALF OF THE CUSTOMER. THE E-0 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED AND WITH MULTIPLE TEST STRIPS. AT THE TIME OF THE CALL THE CUSTOMER STATED THAT HE HAD BLURRY VISION; CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 131MG/DL USING TRUEMETRIX METER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. THE PRODUCT STORAGE WAS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/15/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Blurred Vision

  MAUDE report 7685957 ↗
• MalfunctionJun 22, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 115 TO 135MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BATHROOM. THE TEST STRIP MANUFACTURER'S EXPIRATION DATE IS 02/23/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7629353 ↗
• MalfunctionJun 8, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 160 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/24/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7584472 ↗
• MalfunctionJun 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 227 MG/DL FASTING AND 203 AND 199 MG/DL NON-FASTING. CUSTOMER IS ALSO CONCERNED WITH NON-FASTING BACK TO BACK BLOOD TEST RESULTS PERFORMED DURING THE CALL OF 203 AND 208 MG/DL USING TRUEMETRIX METER. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 130 MG/DL AND NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 180 MG/DL. CUSTOMER ALSO STATED WHEN SHE COMPARES THE RESULTS FROM THE TRUEMETRIX METER TO ANOTHER DEVICE, THE RESULTS FROM THE TRUEMETRIX ARE HIGHER. ACTUAL METER TO METER COMPARISON TEST RESULTS WERE NOT PROVIDED. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :227MG/DL DATE:(B)(6) 2018 TIME:09:32AM FASTING; RESULT 2 :129MG/DL DATE:(B)(6) 2018 TIME:12:23AM FASTING; RESULT 3 :203MG/DL DATE:(B)(6) 2018 TIME:08:58P

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7569646 ↗
• MalfunctionMay 18, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 163 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/25/2018 AND CUSTOMER WAS UNSURE OF OPEN VIAL DATE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7525915 ↗
• MalfunctionMay 11, 2018Material Discolored; Material Discolored

  CONSUMER REPORTED COMPLAINT FOR RUSTY STRIPS AND PREVIOUS MEDICAL ATTENTION. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED ON A PREVIOUS EVENT.. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/28/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER'S DAUGHTER CALLED IN STATING SHE HAD TWO STRIPS IN THE CONTAINER THAT LOOKED RUSTY. ON (B)(6) 2018, CUSTOMER CHECKED HER BLOOD SUGAR IN THE MORNING AND THE RESULTS WAS 248MG/DL FASTING. CUSTOMER CHECKED HER BLOOD SUGAR IN THE EVENING AND RESULTS WERE 326MG/DL FASTING. CUSTOMER'S DAUGHTER DROVE HER TO THE ER, SHE WAS ADMITTED AND DIAGNOSED WITH HYPERGLYCEMIA AND DEHYDRATION. DAUGHTER DOES NOT REMEMBER HER LABS AT THE HOSPITAL, BUT BELIEVES THEY WERE MATCHING THE METER'S RESULTS. CUSTOMER WAS RELEASED ON (B)(6) 2018 AND WITH AN INCREASED ON HER LANTUS. CUSTOMER DECLINED REPLACEMENT OF THE PRODUCTS STATING THAT SHE BELIEVES THE RESULTS WERE ACCURA

  Patient problems: Dehydration; Hyperglycemia

  MAUDE report 7506643 ↗
• MalfunctionApr 4, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 153, 267, 295, 337, 318 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102 - 140 MG/DL. CUSTOMER STATED TRUEMETRIX METER WAS READING HIGH AND THEN ERRATIC AFTER RUNNING THE INITIAL BLOOD RESULTS. CUSTOMER STATED SHE HAS HAD THE TRUEMETRIX METER FOR OVER A YEAR AND THIS JUST STARTED TO HAPPEN WITHIN THE LAST FEW WEEKS. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/14/2019 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:153MG/DL (B)(6) 8:28AM FASTING, RESULT 2:267MG/DL (B)(6) 2:53PM FASTING, RESULT 3:295MG/DL (B)(6) 2:43PM FASTING, RESULT 4:337MG/DL (B)(6) 2:42PM FASTING, RESULT 5:318MG/DL (B)(6) 2:41PM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7395623 ↗
• MalfunctionMar 21, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 130MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE LIVING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:304MG/DL DATE: (B)(6) 2018 TIME:7:13PM FASTING; RESULT 2:HI DATE:(B)(6) 2018 TIME:3:46PM NON-FASTING ; RESULT 3:591MG/DL DATE: (B)(6) 2018 TIME:3:12PM NON-FASTING; RESULT 4:HI DATE:(B)(6) 2018 TIME:3:11PM NON-FASTING ; RESULT 5:306MG/DL DATE: (B)(6) 2018 TIME: 12:37PM FASTING. CUSTOMER GETTING HI DISPLAY ON METER. CUSTOMER SAYS WHEN GETTING HI HE DOES NOT FEEL ANY SYMPTOMS THEREFORE DOES NOT BELIEVE THE METER IS ACCURATE. CUSTOMER DID MENTION A CHANGE IN MEDICATION. SAYS HE DOES NOT REMEMBER THE NAME OF THE MEDICATION BUT SAYS THAT SINCE HE'S BEEN OFF OF IT, RESUL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7360125 ↗
• MalfunctionFeb 15, 2018High Test Results; High Test Results

  CONSUMER INITIALLY REPORTED COMPLAINT FOR HIGH CONTROL GLUCOSE TEST RESULTS. AFTER TROUBLESHOOTING, CUSTOMER ALSO REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 252, 283 AND 205 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140 - 160 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 243 MG/DL AND 227 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2019 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS PRIMARILY CONCERNED WITH THE 252 MG/DL, 283 MG/DL, AND 205 MG/DL READINGS BECAUSE THEY ARE WAY HIGHER THAN HER NORMAL RANGE. CUSTOMER HAD ALSO TAKEN A CONTROL TEST BEFORE AND GOT A 92 MG/DL AND IT DID NOT READ WITHIN THE RANGE OF THE CONTROL SOLUTION LEVEL 2, WHICH WAS 98-132.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7273219 ↗
• MalfunctionJan 22, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LO BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. PRESTON (SON) IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF LO. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 TO 140MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF SWEATINESS AND CONFUSION. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER IN ACCORDING WITH THE SPECIFICATION IN THE BATHROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/21/2018 AND OPEN VIAL DATE IS (B)(6) 2017. TEST STRIPS ARE EXPIRED; OPEN FOR MORE THAT 4 MONTHS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1 :LOMG/DL DATE:(B)(6) 2017 TIME:12:05 PM FASTING, RESULT 2 :LOMG/DL DATE: (B)(6) 2017 TIME:11:38 PM FASTING, RESULT 3 :LOMG/DL DATE (B)(6) 2017 TIME:12:44 PM FASTING, RESULT 4 :LOMG/DL DATE: (B)(6) 2017 TIME:12:13 PM FASTING, RESULT 5 :20MG/DL DATE: (B)(6) 2017 TIME:12:13 PM FASTING.

  Patient problems: Confusion/ Disorientation; Sweating

  MAUDE report 7211066 ↗
• MalfunctionDec 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 217, 206, 236, 190 AND 292 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 103 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET, RESULTS ARE FROM LOG BOOK): (B)(6). CUSTOMER IS CONCERNED WITH ALL RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7087973 ↗
• MalfunctionNov 30, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER INITIALLY CALLED TO ORDER TEST STRIPS. CUSTOMER MENTIONED SHE WAS UNSURE ABOUT AN ERROR MESSAGE SHE HAD BEEN GETTING. AS CUSTOMER WAS UNSURE ABOUT THE ERROR, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING PRIOR TO TROUBLESHOOTING AND PRODUCED TEST RESULTS OF 90 AND 196MG/DL USING TRUEMETRIX METER. CUSTOMER WAS CONCERNED THAT RESULTS WERE ERRATIC. CUSTOMER DID NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME NOT SET): RESULT 1 :196MG/DL DATE: (B)(6) 2017 TIME:01:06PM FASTING. RESULT 2 :90MG/DL DATE: (B)(6) 1207 TIME:01:03PM FASTING. RESULT 3 :112MG/DL DATE: (B)(6) 2017 TIME:09:35AM FASTING. RESULT 4 :171MG/DL DATE: (B)(6) 2017 TIME:06:19PM FASTING. RESULT 5 :108MG/DL DATE: (B)(6) 2017 TIME:10:11AM FASTING. CUSTOMER ORIGINALLY CALLED WANTING TO ORDER TEST STRIPS. THE CUSTOMER WAS UN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7072659 ↗
• MalfunctionNov 30, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS.THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED RESULTS OF 200, 201, 202 AND 219MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130- 170MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE STUDY. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6) 2018 AND OPEN VIAL DATE IS 11/3/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :200MG/DL DATE: (B)(6) 2017 TIME:10:16AM FASTING. RESULT 2 :168MG/DL DATE: (B)(6) 2017 TIME:4:31PM NON- FASTING. RESULT 3 :201MG/DL DATE: (B)(6) 2017 TIME:8:09AM FASTING. RESULT 4 :202MG/DL DATE: (B)(6) 2017 TIME:8:54PM NON- FASTING. RESULT 5 :219MG/DL DATE: (B)(6) 2017 TIME: 7:46AM FASTING. CUSTOMER JUST STARTED TO USE THIS METER 3 DAYS AGO AND SINCE HE USED IT HE WAS GETTING HIGH BLOOD READINGS. HE TOOK HIS METER TO THE DR'S OFFICE SINCE HIS DR. TOLD CUSTOMER THAT WE COULD RUN A TEST ON HER METER AND THE TRUE METRIX METER. THE DR.'S RESULTS, THE CUSTOMER STATED, WAS 130MG/DL AND HE STATED THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7071171 ↗
• MalfunctionNov 16, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 88 AND 164MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 90 AND 164MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/17/18 AND OPEN VIAL DATE IS 10/16/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) (B)(6). CUSTOMER STATES THAT WHEN SHE PERFORMS BACK TO BACK BLOOD TESTS, HER RESULTS ARE ERRATIC IN NATURE. ALL BLOOD GLUCOSE TESTS ARE NORMALLY DONE FASTING. CUSTOMER STATES THAT SHE TESTS UP TO 4 TIMES PER DAY. TIME NOT CURRENTLY SET UP CORRECTLY IN THE METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036831 ↗