TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter (REF RE4095-40)Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 00021292007041), received between Nov 22, 2016 and Jan 7, 2021 — classified as 1 injury, 94 malfunctions.

The most frequently reported specific device problem is “High Test Results” (69 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2021Battery Problem; Battery Problem

  CONSUMER REPORTED COMPLAINT THAT THE METER WOULD NOT POWER ON WHEN A TEST STRIP WAS INSERTED. SISTER IS CALLING ON BEHALF OF THE CUSTOMER WHO WAS NOT AVAILABLE AT THE TIME OF THE CALL. CUSTOMER HAS HAD THE METER FOR OVER 5 YEARS. THE BATTERY HAD BEEN CHANGED THE DAY OF CALL AND DURING THE CALL, THE METER POWERED ON USING THE POWER BUTTON AND WHEN A TEST STRIP WAS INSERTED. SISTER STATED THAT THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11131627 ↗
• InjuryJun 16, 2020Battery Problem; Adverse Event Without Identified Device or Use Problem; Battery Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR LOW BATTERY ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FEELING WEAK. MEDICAL ATTENTION IS REPORTED AS A RESULT. THE CUSTOMER STATED THAT ON (B)(6) 2020, HE WENT TO THE EMERGENCY ROOM BECAUSE HE WAS FEELING WEAK AND TIRED DUE TO HIS DIABETES. THE EMERGENCY ROOM PERFORMED URINE TEST THE RESULT WAS OVER 500 AND ALSO PERFORMED BLOOD TEST RESULT WAS 355 MG/DL. CUSTOMER WAS TREATED WITH INSULIN AND WAS RELEASED AFTER 4 HOURS IN THE EMERGENCY ROOM. CUSTOMER WAS PRESCRIBED GLIPIZIDE AND TO FOLLOW UP WITH HIS DOCTOR. CUSTOMER WILL HAVE AN APPOINTMENT (B)(6) 2020 THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/30/2021 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Hyperglycemia

  MAUDE report 10159447 ↗
• MalfunctionNov 5, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 54 AND 66MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-110MG/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 BEDROOM AND OR LIVING ROOM. DURING THE CALL A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 96MG/DL FASTING USING METER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2020 AND OPEN VIAL DATE IS UNDISCLOSED. (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9278849 ↗
• MalfunctionJul 30, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH ALL HIGH TEST RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNKNOWN. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2020 AND OPEN VIAL DATE IS JULY 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8843117 ↗
• MalfunctionJul 22, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 214, 200 AND 376 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH ERRATIC RESULTS STATING THAT THE RESULTS ON HIS BACK TO BACK TESTS SHOULD BE CLOSER THAN WHAT THEY ARE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 135 - 165 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, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 182 MG/DL AND 191 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE OFFICE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2020 AND TEST STRIPS WERE OPENED ABOUT THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8813563 ↗
• MalfunctionMay 13, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-3 AND E-5 ERROR. THE E-3 ERROR OCCURRED AFTER THE BLOOD SAMPLE AS BEEN APPLIED. CUSTOMER STATED THE E-5 ERROR MESSAGE HAD ALSO BEEN OBTAINED. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING A HEADACHE. DAUGHTER STATED SHE DECIDED TO PERFORM BLOOD GLUCOSE TEST ON CUSTOMER AS SHE HAD NOTICED A CHANGE IN CUSTOMER'S MENTAL HEALTH. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER WAS NOT TESTING WITH A USED TEST STRIP AND DID NOT RECALL ANY TIME WHEN THE TEST STRIP VIAL HAD BEEN LEFT OPEN. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2019 AND TEST STRIPS WERE OPENED ABOUT SIX MONTHS AGO (EXPIRED).

  Patient problems: Headache

  MAUDE report 8606006 ↗
• MalfunctionApr 24, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 425MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS, EXCEPT FOR FEELING SYMPTOMS OF TIREDNESS FOR THE LAST FEW DAYS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN DRAWER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/31/2019 AND OPEN VIAL DATE IS JANUARY 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8546653 ↗
• MalfunctionApr 12, 2019High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW AND HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 69 AND 162 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102 - 127 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING JITTERY. CUSTOMER STATED SHE WILL EAT SINCE SHE HAD NOT EATEN SINCE 3PM AND STATED THAT SHE HAD FELT JITTERY ALSO WHEN SHE HAD OBTAINED THE RESULT OF 69 MG/DL ON (B)(6) 2019; CUSTOMER HAD EATEN SOMETHING AND FELT FINE AFTER. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. DURING THE CALL A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 113 MG/DL USING METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/23/2019 AND TEST STRIPS WERE OPENED ABOUT ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Code Available

  MAUDE report 8511679 ↗
• MalfunctionApr 10, 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 249, 301 AND 315 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 121 MG/DL. CUSTOMER STATED THE HIGH READINGS STARTED SEVERAL 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 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 03/26/2020 AND TEST STRIPS WERE OPENED ONE WEEK AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8500143 ↗
• MalfunctionFeb 28, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 251 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 110 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) 2019, 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 06/18/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8379668 ↗
• MalfunctionFeb 22, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 230 -240MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 286 AND 284MG/DL FASTING USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/28/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8364145 ↗
• MalfunctionFeb 20, 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 160, 159, 145, 141 AND 240 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 99 - 115 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) 2019, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-2 AND E-2 USING TRUEMETRIX METER; CUSTOMER WAS NOT ABLE TO PRODUCE AN ADEQUATE BLOOD SAMPLE. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE IS (B)(6) 2019. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8354051 ↗
• MalfunctionJan 18, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 57 AND 65 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 83 - 105 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 08/27/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :65MG/DL DATE: (B)(6) 2018 TIME:12:27AM FASTING; RESULT 2 :80MG/DL DATE: (B)(6) 2018 TIME:12:26AM FASTING; RESULT 3 :72MG/DL DATE: (B)(6) 2018 TIME:03:33AM FASTING; RESULT 4 :57MG/DL DATE:(B)(6) 2018 TIME:03:50AM FASTING; RESULT 5 :84MG/DL DATE:(B)(6) 2018 TIME:07:25AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8261562 ↗
• MalfunctionJan 16, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 72, 85 AND 78 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL. THE CUSTOMER IS USING THE CORRECT TESTING TECHNIQUE. 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. PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/16/2020, AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN CONCERNED ABOUT LOW RESULTS. ADVISED CUSTOMER OF METER VARIANCE. CUSTOMER IS STORING STRIPS PROPERLY AND IS USING THE CORRECT TECHNIQUE. RAN CONTROL SOLUTION TEST AND RESULTS ARE WITHIN RANGE. CUSTOMER WILL CONTINUE TO USE METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252657 ↗
• MalfunctionJan 11, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-2 ERROR CODE. HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. THE E-2 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. THE CUSTOMER WAS USING THE CORRECT TEST STRIPS FOR THE METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/17/2019, AND OPEN VIAL DATE IS (B)(6) 2018. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF E-2 USING TRUEMETRIX METER. AT THE TIME OF THE CALL, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. ON (B)(6) 2018, THE CUSTOMER HAD NOT BEEN FEELING WELL AND HAD GONE TO THE ER. CUSTOMER WAS DIAGNOSED WITH LOW BLOOD SUGAR; HUSBAND DID NOT KNOW WHAT THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WAS AT THE HOSPITAL. HUSBAND DID NOT RECALL WHAT TREATMENT CUSTOMER WAS GIVEN BUT STATED SHE WAS GIVEN SOMETHING TO BRING HER BLOOD GLUCOSE LEVEL UP. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2018, AND WAS ADVISED TO FOLLOW-UP WITH HER PRIMARY CARE DOCTOR (CUSTOMER HAS AN APPOINTMENT ON FRIDAY). ADDITIONAL BLOOD TESTS WERE PERFORMED USING THE TRUEMETRIX METER.

  Patient problems: Hypoglycemia

  MAUDE report 8240691 ↗
• MalfunctionDec 7, 2018Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL RESULTS. THE CUSTOMER IS CONCERNED WITH CONTROL TESTS RESULTS OF 61MG/DL. THE EXPECTED LEVEL 1 CONTROL SOLUTION RANGE IS 23-53MG/DL. CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE IS 11/16/2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED FOR ASSISTANCE RUNNING CONTROL TEST BEFORE USING METER. CONTROL RESULT WAS OUT OF RANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8144013 ↗
• MalfunctionSep 28, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED AS SOON AS THE BLOOD SAMPLE WAS ABSORBED. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF HI AND HI USING TRUEMETRIX METER. CUSTOMER STATED HE HAD BREAKFAST ALMOST 2 HOURS AGO AND THAT HE HAD TOO MUCH SYRUP WITH HIS FRENCH TOAST. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 140 MG/DL. CUSTOMER IS ON AN INSULIN PUMP AND STATED THAT HE TENDS TO RUN HIGH AND LOW AT TIMES. CUSTOMER ADMINISTERED 12 U OF HUMULIN VIA INSULIN PUMP WHILE ON THE CALL. CUSTOMER WAS NOT CONCERNED WITH THE RESULT OF 57 MG/DL IN THE METER'S MEMORY. 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 06/15/2019 AND OPEN VIAL DATE IS ABOUT THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7919835 ↗
• MalfunctionSep 10, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-3 BLOOD GLUCOSE RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF HAVING A HEADACHE AND FEELING DIZZY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-3 USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/20/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Dizziness; Headache

  MAUDE report 7861361 ↗
• MalfunctionSep 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 135, 152, 196, 138 AND 203 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 103 - 118MG/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 BATHROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/19/2019 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 7842502 ↗
• MalfunctionAug 24, 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 140, 125, 215, 269 AND 323 MG/DL. CUSTOMER DID NOT KNOW IF THE RESULTS WERE FASTING OR NON-FASTING. CUSTOMER DID NOT KNOW HIS EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. DURING THE CALL ON (B)(6) 2018, THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED NON-FASTING DURING CALL ON (B)(6) 2018 PRODUCED RESULT OF 318 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/27/2019 AND OPEN VIAL DATE IS ONE MONTH. DURING THE CALL ON (B)(6) 2018, THE CUSTOMER MIXED THE TEST STRIPS WITH ANOTHER BRAND OF STRIPS. ADVERSE EVENT NOT REPORTED AT TIME OF CALL ON (B)(6) 2018.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7813867 ↗
• MalfunctionAug 6, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 180, 162, AND 171 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-120 MG/DL. CUSTOMER STATED THAT THE RESULTS HAVE BEEN HIGH SINCE OPENING A NEW BOTTLE OF STRIPS. CUSTOMER IS NOT USING ALCOHOL PADS OR SANITIZER. CUSTOMER HAS BEEN TESTING BOTH BEFORE A MEAL AND TWO HOURS AFTER. 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 211 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/20/2019 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 7754614 ↗
• MalfunctionJun 8, 2018Low Test Results; Low Test Results

  CONSUMER COMPLAINT OF E-5 ERROR. E-5 ERROR OCCURRED AFTER BLOOD SAMPLE APPLIED TO TEST STRIP. CUSTOMER FEELS WELL AND OBSERVED NO SYMPTOMS. MEDICAL INTERVENTION IS NOT REPORTED AT THE TIME OF THE CALL ON (B)(6) 2018 AS A RESULT OF THE METER'S READINGS. BLOOD TEST PERFORMED FASTING DURING CALL ON (B)(6) 2018 PRODUCED RESULT OF E-5 AFTER BLOOD SAMPLE APPLIED TO TEST STRIP. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/29/2019 AND OPEN VIAL DATE IS (B)(6) 2018. ADVERSE EVENT NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7584121 ↗
• MalfunctionMay 22, 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 201, 183, 164 AND 199 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 130 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. CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) 2018. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS (B)(6) 2019 AND OPEN VIAL DATE IS FEW WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7535290 ↗
• MalfunctionMay 14, 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 125-130MG/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 BEDROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 277 AND 259MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/22/2018 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). CUSTOMER STATES THAT SINCE YESTERDAY THE RESULTS ARE IN THE 200-300 MG/DL. CUSTOMER STATES THAT NOTHING HAVE CHANGE TO MAKE HER GLUCOSE GONE UP SO HIGH. CHECK THE METERS MEMORY AND THE TIME AND DATE NOT SET. STRIPS ARE BEING STORED CORRECTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7511334 ↗
• MalfunctionMay 7, 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 150MG/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 DINING ROOM. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 341 AND 255MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 3/31/2019 AND OPEN VIAL DATE IS ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH THE HIGH RESULTS THAT HE IS GETTING FROM HIS METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7490965 ↗