TRUE METRIX TRUE METRIX SELF MONITORING BLOOD GLUCOSE METER (REF RE4H01-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 329 adverse event reports that list this exact device (DI 00021292006051), received between Nov 22, 2016 and Jan 22, 2019 — classified as 329 malfunctions.

The most frequently reported specific device problem is “High Test Results” (213 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 329 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 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 591, 528, 373, 519 AND 313 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 300 MG/DL. CUSTOMER STATED SHE IS USING CORRECT TESTING TECHNIQUE. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED HAVING A HEADACHE. CUSTOMER STATED SHE WOULD SEEK MEDICAL ATTENTION AND WAS WAITING FOR HER DAUGHTER TO PICK HER UP. CUSTOMER STATED SHE WAS ABLE TO CONTINUE WITH THE CALL. CUSTOMER STATES AT AN EARLIER TIME, SHE DOES NOT REMEMBER THE EXACT DATE, THE TRUEMETRIX METER HAD READ IN THE 500'S FASTING (CUSTOMER DOES NOT REMEMBER EXACT RESULT). CUSTOMER STATED SHE THEN TOOK INSULIN (CUSTOMER DOES NOT REMEMBER HOW MUCH). CUSTOMER THEN WAS SHAKY, ANXIOUS AND HAD A HEADACHE AND WENT IN TO THE ER. CUSTOMER STATED SHE WAS TESTED AT THE ER, WHICH WAS ABOUT 20 MINUTES AFTER TESTING AT HOME AND THE RESULT WAS 69 MG/DL. THE DIAGNOSIS WAS HYPOGLYCEMIA AND CUSTOMER STATED SHE WAS GIVEN SOME TYPE OF GLUCOSE LIQUID TO RAISE HER BLOOD SUGAR (DOES NOT REMEMBER EXACTLY WHAT IT WAS). NO NEW HEALTHCARE PROGRAM OR MEDICATIONS HAD BEEN SUGGESTED. DURING THE

  Patient problems: Headache; Hypoglycemia; Shaking/Tremors

  MAUDE report 8268948 ↗
• MalfunctionJan 21, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95-120MG/DL. THE 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 BATHROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/20/2020, AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). COMPLAINT CUSTOMER CALLED IN STATING THAT HE HAS TWO METERS, AND BOTH ARE READING HIGHER THAN HIS EXPECTED RANGE. CUSTOMER IS ALSO COMPARING THE METERS TO ANOTHER METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8264863 ↗
• MalfunctionJan 18, 2019Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-150 MG/DL. THE 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 03/31/2020, 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 8261020 ↗
• MalfunctionJan 17, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CUSTOMER REPORTED COMPLAINT STATING SHE SEES ERR. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING TIRED AND DIZZY. CUSTOMER WAS INSTRUCTED TO SEEK MEDICAL INTERVENTION. CUSTOMER'S TEST STRIPS ARE EXPIRED - MANUFACTURER'S EXPIRATION DATE IS 01/26/2018.

  Patient problems: Dizziness; Fatigue

  MAUDE report 8257946 ↗
• MalfunctionJan 16, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF HI. CUSTOMER JUST STARTED TO USE THE TRUEMETRIX METER; SHE HAD PERFORMED TWO BLOOD TESTS AND BOTH RESULTS OBTAINED WERE HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 140 MG/DL. ALTHOUGH THE CUSTOMER FELT WELL AND DID NOT REPORT ANY SYMPTOMS, SHE STATED SHE WAS GOING TO SEEK MEDICAL INTERVENTION. 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. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/19/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: HI DATE:(B)(6) 2018 TIME:2:05PM FASTING, RESULT 2: HI DATE:(B)(6) 2018 TIME:2:04 PM FASTING.

  Patient problems: Hyperglycemia

  MAUDE report 8252600 ↗
• MalfunctionJan 10, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR CODE. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED SYMPTOMS OF DRY MOUTH, NAUSEA AND FEELING TIRED. DAUGHTER STATED SHE WAS GOING TO TAKE CUSTOMER TO THE HOSPITAL. DAUGHTER STATED THAT CUSTOMER OBTAINED THE E-5 ERROR ON TWO DIFFERENT METERS; NOT ABLE TO OBTAIN INFORMATION FOR THE SECOND METER AT THE TIME OF THE CALL.

  Patient problems: Fatigue; Nausea; Polydipsia

  MAUDE report 8236513 ↗
• MalfunctionJan 2, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR CODE AND HI DISPLAY. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF EXCESSIVE THIRST, BLURRY VISION, FREQUENT URINATION AND FEELING WEAK AND TIRED. MEDICAL ATTENTION WAS REQUIRED AND CUSTOMER WAS GOING TO CALL 911. CUSTOMER HAD CALLED BACK ON (B)(6) 2018, AND FURTHER INFORMATION WAS ABLE TO BE OBTAINED. THE CUSTOMER REPORTED THAT HIS CONDITION HAD IMPROVED AND HE DID NOT CURRENTLY HAVE ANY DIABETIC SYMPTOMS. ON (B)(6) 2018, THE CUSTOMER HAD CALLED THE AMBULANCE. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL WAS IN THE 700'S. THE CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS GIVEN INSULIN. THE CUSTOMER WAS DISCHARGED THE SAME DAY; NO NEW MEDICATIONS OR HEALTHCARE PROGRAM WAS SUGGESTED. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200 - 300 MG/DL. 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 522 MG/DL AND 520 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVIN

  Patient problems: Blurred Vision; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 8208276 ↗
• MalfunctionDec 26, 2018Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH ALL THE TESTS RESULTS OBTAINED. THE EXPECTED NON- FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 200MG/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. DURING THE CALL ON 12/03/2018, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER (DECLINED). THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2020 AND OPEN VIAL DATE IS 11/26/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1 :127MG/DL, DATE: (B)(6) 2020, TIME:05:26 PM, N/FASTING; RESULT 2 :105MG/DL, DATE: (B)(6) 2020, TIME:12:56 PM, N/FASTING; RESULT 3 :113MG/DL, DATE: (B)(6) 2020, TIME:12:54PM, N/FASTING; RESULT 4 :106MG/DL, DATE: (B)(6) 2020, TIME:12:53PM, N/FASTING; RESULT 5 :127MG/DL, DATE: (B)(6) 2020, TIME:05:26PM, N/FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196986 ↗
• MalfunctionDec 26, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 208, 159, 162, 204 AND 167 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 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 STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM IN A DESK DRAWER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2020 AND OPEN VIAL DATE WAS LAST WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196468 ↗
• MalfunctionDec 18, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. WIFE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF 460MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120-160MG/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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/18/2020 AND OPEN VIAL DATE IS 09/01/2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8174756 ↗
• MalfunctionDec 17, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-121MG/DL. THE 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 03/19/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:164MG/DL DATE: (B)(6) 2018 TIME:12:36PM FASTING. RESULT 2:131MG/DL DATE: (B)(6) 2018 TIME:12:14PM FASTING. RESULT 3:158MG/DL DATE: (B)(6) 2018 TIME:11:26AM FASTING. RESULT 4:206MG/DL DATE: (B)(6) 2018 TIME:11:13AM FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8168935 ↗
• MalfunctionDec 14, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E--5 BLOOD GLUCOSE TEST RESULTS ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING TIRED AND EXTREMELY THIRSTY. 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) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF E-5 USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/29/2019, AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. THE CUSTOMER IS SEEING THE E5 AFTER THE BLOOD SAMPLE HAS BEEN APPLIED. THE E5 ERROR APPEARED WHEN THE CUSTOMER PERFORMED THE BLOOD TEST DUE TO NURSE STATED THAT CUSTOMER DOES RUN HIGH AND HAVE SYMPTOMS.

  Patient problems: Fatigue; Polydipsia

  MAUDE report 8164628 ↗
• MalfunctionDec 12, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. MOTHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 364, 339 AND 319 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 140 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. THE CUSTOMER WAS NOT ABLE 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 02/24/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER WAS UNABLE TO SEE THE TIME, BUT STATED TESTS WERE PERFORMED BACK-TO-BACK):(B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8154917 ↗
• MalfunctionDec 7, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF EXCESSIVE URINATION, EXCESSIVE THIRST, AND FEELING WEAK. 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-5 USING TRUE METRIX METER. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/15/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED IN STATES THAT HE IS GETTING ERROR. WHILE ATTEMPTING TO RUN A PROPER BLOOD TEST METER READ E-5. CUSTOMER STATES HE HAS EXCESSIVE URINATION, EXCESSIVE THIRST, AND FEELS WEAK. INFORMED CUSTOMER E-5 MEANS TEST STRIP ERROR OR THAT HIS BLOOD SUGAR IS ABOVE 600MG/DL. INSTRUCTED CUSTOMER TO CALL 911 OR TO GO TO THE HOSPITAL. CUSTOMER STATES ONCE WE HANG UP HE WILL CALL 911.

  Patient problems: Polydipsia; Urinary Frequency / Polyuria; Weakness

  MAUDE report 8142169 ↗
• MalfunctionDec 6, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 120MG/DL OR UNDISCLOSED. 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 DINING ROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 229 AND 197MG/DL NON-FASTING USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 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 8139882 ↗
• MalfunctionDec 6, 2018High Test Results; Adverse Event Without Identified Device or Use Problem; High Test Results; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. 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 PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI DISPLAY USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE IS YESTERDAY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. HI DISPLAY 11/ 1113 820A FASTING. 560MG/DL 11/12 1046A FASTING. CUSTOMER ONLY HAS TWO READINGS. CUSTOMER CALLED REGARDING E-2 ERROR MESSAGE. CCR REP EDUCATED CUSTOMER AND ATTEMPTED TO TROUBLE SHOOT. WHILE PERFORMING A BLOOD TEST CUSTOMER GOT HI AS A RESULT. CUSTOMER STATED THAT HE DOES NOT HAVE ANY SYMPTOMS. CUSTOMER IS STORING STRIPS PROPERLY. CUSTOMER WAS RELEASE FROM THE HOSPITAL RECENTLY DUE TO KIDNEY TRANSPLANT, CUSTOMER IS ALSO ON STEROID MEDICATION FOR THE SURGERY. CUSTOMER TESTED WHILE IN THE HOSPITAL AND BLOOD SUGAR WAS IN THE 500'SMG/DL. CUSTOMER RECEIVED OUR METER YESTERDAY AND

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8137491 ↗
• MalfunctionDec 5, 2018Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  CONSUMER REPORTED COMPLAINT FOR E-5 ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140-150MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF VOMITING. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. VERIFIED STORAGE OF PRODUCT IS WITHIN INSTRUCTED SPECIFICATION SINCE THEY ARE RETAINED IN THE BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/25/2019 AND OPEN VIAL DATE IS UNKNOWN. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER WAS THROWING UP AND WAS NOT FEELING GOOD. CUSTOMER HAD TO GO TO THE HOSPITAL. PATIENT IS CURRENTLY IN THE HOSPITAL SINCE (B)(6) 2018, WITH A DIAGNOSIS OF DKA (DIABETIC KETOACIDOSIS). RESULTS AT THE HOSPITAL ON 11/10/2018 WAS OVER 600 MG/DL FASTING. CUSTOMER WAS TREATED VIA INSULIN DRIP. CUSTOMER IS STILL IN THE HOSPITAL. CUSTOMER IS FEELING FINE AND IS NO LONGER EXPERIENCING SYMPTOMS. CUSTOMER DECLINED A REPLACEMENT METER.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 8135733 ↗
• MalfunctionDec 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-100MG/DL. THE CUSTOMER 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 BATHROOM. 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 08/31/2019 AND OPEN VIAL DATE IS 5 DAYS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6). CUSTOMER STATES THAT HER DOCTOR PUT HER ON TWO NEW INSULIN. CUSTOMER RUN A BACK TO BACK TEST AND GOT 50-POINT DIFFERENT ON THE SAME HAND SAME DROP OF BLOOD. I REVIEW WITH CUSTOMER ABOUT PROPER BACK TO BACK TESTING AND CUSTOMER STATES THAT SHE IN UNABLE TRUST THE METER. CUSTOMER STATES THAT SOME OF HER RESULTS ARE HIGH BLOOD AND ERRATIC CUSTOMER NORMAL GLUCOSE RANGE IS 90-100MG/DL FASTING, AND SHE TEST 2 TIMES DAY. STRIPS ARE BEING STORED IN THE BATHROOM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8135457 ↗
• MalfunctionDec 5, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT FEELING WELL AND DID NOT DISCLOSURE ANY DETAILS OF THE SYMPTOMS. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. 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 04/26/2019, AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED IN AND LEFT A VOICEMAIL REQUESTING ASSISTANT. CONTACTED CUSTOMER. CUSTOMER ANSWERED AND STATES THAT THE METER WAS READING WRONG. CUSTOMER PROVIDED A LOT NUMBER THAT WAS CLOSE TO ITS EXPIRATION DATE. ASKED CUSTOMER HOW LONG SHE HAS BEEN USING THIS VIAL OF TEST STRIPS, SHE STATES THAT SHE HAS ANOTHER VIAL AND WANTED TO USE IT. PERFORMED A BACK TO BACK TEST WITH CUSTOMER USING THE NEW VIAL SHE PROVIDED, THE RESULTS WERE 292 AND 298 MG/DL FASTING. PROCEEDED TO EDUCATE CUSTOMER REGARDING ERRATIC RESULTS AND BACK TO BACK TESTIN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134464 ↗
• MalfunctionNov 19, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM METER TO METER COMPARISON OF 180 MG/DL USING TRUEMETRIX METER AND 114 MG/DL USING DOCTOR DEVICE AND FROM RESULTS OBTAINED OF 172, 220 AND 143 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 100 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 STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/26/2019 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 8085317 ↗
• MalfunctionNov 19, 2018High Test Results; Low Test Results; High Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW AND HIGH BLOOD GLUCOSE RESULTS. FATHER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOM OF FATIGUE. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE CAR. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY CUSTOMER CALLED IN STATES THE METER IS READING LOW BLOOD AND HIGH BLOOD RESULTS. CUSTOMER WAS NOT FEELING WELL HYPERGLYCEMIC SYMPTOMS OF FATIGUE. CUSTOMER DECLINED MEDICAL ATTENTION. CUSTOMER BECAME VULGAR AND WHILE CONDUCTING BACK TO BACK BLOOD TEST CUSTOMER RECEIVED E-3 TWICE. CUSTOMER STATES HE WILL DISCONTINUE USE OF METER AND SUPPLIES AND REFUSE TO ANSWER FURTHER QUESTIONS AND DISCONNECTED CALL. I WILL FOLLOW UP WITH THE CUSTOMER.

  Patient problems: Fatigue

  MAUDE report 8084252 ↗
• MalfunctionNov 16, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 200MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 75 TO 93MG/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 CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 154 AND 181MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2020 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 8081032 ↗
• MalfunctionNov 13, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 277 AND 212MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING DIZZY AND IN A FOG. MEDICAL ATTENTION IS NOT 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 PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 259 AND 273MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 4/30/2020 AND OPEN VIAL DATE IS THREE WEEKS AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY). (B)(6).

  Patient problems: Dizziness

  MAUDE report 8065562 ↗
• MalfunctionNov 9, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FEELING 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 03/19/2020 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY): RESULT 1:197MG/DL DATE: (B)(6) 2018 TIME:2:50PM FASTING; RESULT 2:230MG/DL DATE: (B)(6) 2018 TIME:2:48PM FASTING; RESULT 3:223MG/DL DATE: (B)(6) 2018 TIME:2:45PM FASTING; RESULT 4:164MG/DL DATE: (B)(6) 2018 TIME:12:19PM FASTING; RESULT 5:266MG/DL DATE: (B)(6) 2018 TIME:9:16AM FASTING; CUSTOMER IS NOT SURE WHAT HER NORMAL GLUCOSE RANGE SHOULD BE, CUSTOMER HAVE NOT TESTING IN YEARS CUSTOMER AND JUST STARTED TESTING AGAIN TODAY. CUSTOMER JUST GOT THE METER BECAUSE SHE WILL BE HAVING SURGERY SOON AND SHE

  Patient problems: Sweating

  MAUDE report 8057074 ↗
• MalfunctionNov 9, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS.THE CUSTOMER IS CONCERNED WITH ALL THE RESULTS OBTAINED. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 110-120MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS 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 NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/25/2018 AND OPEN VIAL DATE IS LAST WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY)(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8056875 ↗