TRUE METRIX TRUE METRIX self monitoring blood glucose meter (REF RE4089-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00052569138526), received between Jan 26, 2017 and Nov 8, 2018 — classified as 30 malfunctions.

The most frequently reported specific device problem is “High Test Results” (21 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM BACK TO BACK BLOOD TESTS OF 96 AND 223 MG/DL. CUSTOMER JUST STARTED TO USE THE TRUEMETRIX METER AND TESTS STRIPS (B)(6) 2018 AND HAD ONLY OBTAINED THOSE TWO RESULTS. THE CUSTOMER DID NOT KNOW HER 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. DURING THE CALL ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 132 MG/DL AND 128 MG/DL USING TRUEMETRIX METER. 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) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER WHO JUST GOT THE METER AND STRIPS ON SATURDAY RAN HER BLOOD AND GOT ERRATIC RESULTS. SHE DID NOT DO ANY OTHER RESULTS CALLED US TO ASSIST HER WITH THE METER. I RAN THE BLOOD WITH HER 132MG/DL AND THEN 128MG/DL WHICH WAS WELL WITHIN A 15% VARIANCE. CUSTOMER STATED SHE IS APPLYING THE BL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8052192 ↗
• MalfunctionOct 2, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF 189 AND 116MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 95 TO 105MG/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 NOT PERFORMED. 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: (DATE/TIME NOT STORED CORRECTLY) (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7927359 ↗
• MalfunctionSep 27, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULT. GRANDMOTHER IS CALLING ON BEHALF OF THE CUSTOMER, HER (B)(6) YEAR OLD GRANDSON. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS OF HI, 417, 215, 246 AND 218 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 140 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING ILL AND WAS HAVING SYMPTOMS OF FREQUENT URINATION AND INCREASED THIRST. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. 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 08/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 7915342 ↗
• MalfunctionAug 31, 2018Unable 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 SYMPTOM OF FREQUENT URINATION. CUSTOMER STATES HE ALWAYS HAD FREQUENT URINATION BECAUSE OF HIS DIABETES. 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 BEDROOM. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 193 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS DATE AND OPEN VIAL DATE IS (B)(6) 2018.. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Urinary Frequency / Polyuria

  MAUDE report 7836915 ↗
• MalfunctionAug 14, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 115, 163, 118, 213 AND 196 MG/DL. THE CUSTOMER WAS USING CORRECT TESTING TECHNIQUE. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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. THE CUSTOMER WAS UNABLE TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL ON (B)(6) "2019". THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/29/2019 AND OPEN VIAL DATE IS JULY 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7782329 ↗
• MalfunctionJul 17, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED AS SOON AS THE TEST STRIP WAS INSERTED INTO THE METER. AT THE TIME OF THE CALL ON (B)(6) 2018, THE CUSTOMER REPORTED FEELING ILL WITH SYMPTOMS OF BLURRY VISION AND FATIGUE AND MANUFACTURER CONTACTED 9-1-1 FOR CUSTOMER. CUSTOMER WAS UNABLE TO CONTINUE WITH THE CALL AND NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Blurred Vision; Fatigue

  MAUDE report 7694286 ↗
• MalfunctionJul 5, 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 502 AND 413 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 150 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 382 MG/DL AND 253 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/16/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (B)(6). THE CUSTOMER IS CALLING BECAUSE SHE FEELS THAT THE RESULTS SHE IS GETTING FROM THE METER ARE READING HIGH. THE CUSTOMER STATED THAT SHE IS BATTLING WITH TRYING TO GET HER BLOOD SUGAR DOWN BUT KNOWS IT SHOULD NOT BE AS HIGH AS THE METER IS READING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7665253 ↗
• MalfunctionMay 15, 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 191, 181, 199, 228 AND 217 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 120 - 150 MG/DL. CUSTOMER STATED HE STARTED TO USE THE TRUEMETRIX METER IN JANUARY AND SINCE THEN HAS BEEN OBTAINING HIGH RESULTS. CUSTOMER ALSO STATED THAT THE TRUEMETRIX METER IS READING HIGHER THAN ANOTHER DEVICE; 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. 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 CLOSET. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/24/2019 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 7516289 ↗
• MalfunctionMay 11, 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 RESULTS OBTAINED OF 175 AND 190 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102 - 119 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 BEDROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. NOT ABLE TO REVIEW THE METER MEMORY AS CUSTOMER STATED THAT THE METER DID NOT TURN ON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7506861 ↗
• MalfunctionApr 9, 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 260, 190, 213, 237 AND 184 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 124-134 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH ERRATIC TEST RESULTS BUT RESULTS PROVIDED WERE NOT REPORTED AS BEING PERFORMED BACK TO BACK. 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 238 MG/DL AND 244 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2019 AND OPEN VIAL DATE IS ONE WEEK. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN CONCERNED WITH THE RESULTS HE RECEIVED FROM THE METER. CUSTOMER IS CONCERNED THAT THE METER KEEPS JUMPING FROM ON RESULTS TO ANOTHER WHEN HE TESTS ON HIS FOREARM. CUSTOMER STATES THAT THE RESULTS ARE ALMOST 100 POINTS DIFFERENT WHEN HE TOOK WITHIN 2 HOUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7406979 ↗
• MalfunctionDec 28, 2017High 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 128, 228, 205, 219 AND 189 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. 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 02/25/2019 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS CONCERNED WITH HIGH RESULTS. CUSTOMER IS CONCERNED WITH ALL OF THE RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7151158 ↗
• MalfunctionDec 12, 2017High 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 199 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 88 - 125 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 BATHROOM. 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).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7107748 ↗
• MalfunctionOct 25, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI ACCOMPANIED BY SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 148-150MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF THIRST. 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 LIVING ROOM. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 230 AND 236MG/DL USING TRUE METRIXMETER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. RESULT 1 : 236MG/DL DATE: (B)(6) 2017TIME: 13:03 FASTING. RESULT 2 : 230 MG/DL DATE: (B)(6) 2017TIME: 15;25 05:58FASTING. RESULT 3 : 280 MG/DL DATE: (B)(6) 2017TIME: 14:03 FASTING. RESULT 4 : 336MG/DL DATE: (B)(6) 2017 TIME: 12:37 FASTING. RESULT 5 : HI DATE: (B)(6) 2017 TIME: 09:51FASTING.

  Patient problems: Polydipsia

  MAUDE report 6976462 ↗
• MalfunctionSep 19, 2017High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER INITIALLY REPORTED COMPLAINT FOR E-3 ERROR; USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. THE E-3 ERROR OCCURRED AS SOON AS THE TEST STRIP WAS INSERTED. CUSTOMER CALLED IN WITH WIFE'S ASSISTANCE. CUSTOMER ALSO REPORTED COMPLAINT FOR HIGH RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 333MG/DL . THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 126 - 145 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)(4) 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 11/16/2018 AND OPEN VIAL DATE IS 08/24/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (CUSTOMER HAD ONLY OBTAINED ONE RESULT): 333MG/DL, (B)(6) 2017, 12:27 PM ,FASTING: YES. MEMORY CONCERNS: 333MG/DL. CUSTOMER CALLED IN WITH HIS WIFE'S ASSISTANCE AND STATES THAT HIS METER IS READING HIGH FOR HIM. WIFE STATES CUSTOMER IS NOT DIABETIC JUST MONITORING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6875984 ↗
• MalfunctionSep 15, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED AFTER THE BLOOD SAMPLE IS ABSORBED. THE CUSTOMER WAS USING PROPER TESTING TECHNIQUE. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED HAVING INCREASED THIRST AND INCREASED URINATION. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/31/2018 AND OPEN VIAL DATE AT TIME OF CALL IS ONE WEEK. THE CUSTOMER RECEIVED THE E-5 ERROR WITH ANOTHER VIAL OF TEST STRIPS: LOT NUMBER MU2300, MANUFACTURER'S EXPIRATION DATE OF 06/22/2018, OPEN VIAL DATE UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 6868511 ↗
• MalfunctionAug 28, 2017High 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 130MG/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 BY CUSTOMER ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2018 AND OPEN VIAL DATE IS APPROXIMATELY ONE MONTH. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: A 185MG/DL (B)(6)2017 05:31 PM FASTING: YES. A 148MG/DL (B)(6)2017 02:34 PM FASTING: YES. A 192MG/DL (B)(6)2017 11:29 AM FASTING: YES. A 159MG/DL (B)(6)2017 01:43 PM FASTING: YES. A 188MG/DL (B)(6)2017 01:48 PM FASTING: YES. CUSTOMER CALLING CONCERN WITH THE METER GIVING HIGH BLOOD RESULTS. CUSTOMER STATES THAT HER A1C LAST MONTH WAS 7.9. (180MG/DL).CUSTOMER STATES THAT SINCE THEN SHE HAVE STOP EATING THE CARB, AND SWEETS AND STILL GETTING RESULTS IN THE 200SMG/DL .CUSTOMER STATES THAT SINCE (B)(6)2017 SHE HAVE CHANGE HERE EATING HABITS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6825481 ↗
• MalfunctionAug 8, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 427 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 - 200 MG/DL. DAUGHTER STATED CUSTOMER FEELS THIRSTY BUT DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. 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 09/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Polydipsia

  MAUDE report 6773527 ↗
• MalfunctionAug 7, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH THE RESULT OF 186, 172 AND 162 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 140 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 STORED BY CUSTOMER ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 125 AND 99 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/30/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (DATE/TIME NOT STORED CORRECTLY). (B)(6). CUSTOMER IS CONCERNED WITH HIGH READINGS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6772832 ↗
• MalfunctionJun 27, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH THE RESULTS REPORTED OF 226MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 180MG/DL. THE CUSTOMER DID REPORT EXPERIENCING HYPERGLYCEMIC SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT NOT STORED ACCORDING TO THE SPECIFICATIONS IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/28/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER REFUSES TO RUN A TEST AT THE TIME OF CALL SINCE HER HUSBAND PRICKED HIS FINGER 4 TIMES BEFORE CONTACTING US. CUSTOMER WAS ABLE TO OBTAIN A READING PRIOR TO THE CALL OF 226MG/DL. CUSTOMER DID NOT ADVISE IF 226MG/DL WAS FASTING OR NON-FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6671960 ↗
• MalfunctionJun 5, 2017High 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. CUSTOMER STATED HE HAD TESTED WITH TEST STRIP LOT # MT2249. CUSTOMER STATED HE HAD ANOTHER VIAL OF TEST STRIPS (MT2261), WHICH HE USED DURING THE CALL ON (B)(6) 2017. WHILE TROUBLESHOOTING THE E-5 ERROR, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF HI USING TRUEMETRIX METER (CUSTOMER STATED THAT HE HAD TWO GLASSES OF ORANGE JUICE AND THREE EGGS PRIOR TO TAKING THIS READING). DURING THE CALL ON (B)(6) 2017, THE CUSTOMER REPORTED FEELING FATIGUE, EXCESS URINATION, THIRST, BLURRY VISION, AND SHAKY. CUSTOMER INITIALLY DENIED MEDICAL ATTENTION, BUT PRIOR TO CALL ENDING, CUSTOMER REQUESTED THAT 9-1-1 BE CALLED FOR HIM. 9-1-1 WAS CALLED AND REPRESENTATIVE STAYED ON THE LINE, SPOKE TO PARAMEDIC AND REQUESTED THEY RUN A BLOOD TEST WITH THEIR METER. PARAMEDIC STATED THAT THEIR METER IS ALSO READING HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 180 - 200 MG/DL. DURING THE CALL ON (B)(6) 2017, TWO ADDITIONAL BLOOD TESTS WERE PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF E-5 USING TRUEMET

  Patient problems: Fatigue; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 6613214 ↗
• MalfunctionJun 5, 2017Low 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 53MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 121 TO 168MG/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 PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/19/2018 AND OPEN VIAL DATE IS 04/01/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 1:53MG/DL (B)(6) 2017 08:29 AM FASTING: YES. CUSTOMER IS NOT PERFORMING THE BACK TO BACK TEST BECAUSE CUSTOMER HAS STRIPS IN THE KITCHEN. CUSTOMER HAS NOT HAD ANY CHANGES IN HER DIET, MEDICATION OR EXERCISE. CUSTOMER COULD NOT GIVE ME ANY MORE TEST RESULTS THAT WERE LOW FROM HER METER'S MEMORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6610988 ↗
• MalfunctionMay 11, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK FASTING BLOOD TESTS OF 133 AND 336 MG/DL. CUSTOMER STATES IT HAS HAPPENED BEFORE AS WELL ON (B)(6) 2017 AT 6:59 PM OBTAINING A READING OF 152 MG/DL AND 221 MG/DL BACK TO BACK; CUSTOMER DOES NOT RECALL IF THESE READINGS WERE FASTING. CUSTOMER IS ALSO CONCERNED THAT READINGS ARE HIGH. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85 - 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) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 96 MG/DL USING TRUEMETRIX METER AND 114 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2017 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: 133MG/DL (B)(6) 2017 12:22 PM FASTING:YES, 336MG/DL (B)(6) 2017 12:21 PM FASTING:YES, 334MG/DL (B)(6) 2017 12:20 PM FASTING:YES, 152MG/DL (B)(6) 2017 06:59

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6560986 ↗
• MalfunctionMay 3, 2017High 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 234, 208 AND 144 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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 04/22/2018 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. CUSTOMER STATED THAT HE HAS HAD NO CHANGES TO HIS EXERCISE OR DIET ROUTINE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6540152 ↗
• MalfunctionMay 2, 2017High 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 554 AND 519 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 130 TO 140 MG/DL. THE CUSTOMER DID REPORT FEELING DROGGY. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS AT THE TIME OF THE CALL. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. DURING THE CALL ON (B)(6) 2017 A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 554 AND 519 MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/28/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): 1:554 MG/DL (B)(6) 2017 09:25 AM FASTING: YES, 2:519 MG/DL (B)(6) 2017 09:30 AM FASTING: YES. CUSTOMER CALLED BECAUSE BLOOD GLUCOSE WAS ELEVATED. CUSTOMER IS GOING TO GO TO "DOC IN THE BOX" AND CUSTOMER HAS BEEN ON PREDNISONE. CUSTOMER DOES NOT HAVE HGA1C. CUSTOMER HAS NEW INFECTION- YEAST INFECTION. CUSTOMER ON NEW MEDICATION- MYSTATIN 100,000 UNITS/ML AND HE JUST STARTED TAKING THIS 4

  Patient problems: No Code Available

  MAUDE report 6538306 ↗
• MalfunctionApr 6, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 150 TO 200MG/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 PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER CALLED INQUIRING ABOUT HI READING. INFORMED CUSTOMER IF BLOOD LEVEL IS ABOVE 600 MG/DL METER WILL READ HI. READING WAS OBTAINED LAST NIGHT AND CUSTOMER STATES SHE HAD NOT MEDICATED AS PRESCRIBED. THIS MORNING HER READING WAS 200 MG/DL AND READING OBTAINED ON CALL WAS 423 MG/DL NON-FASTING. CUSTOMER STATES SHE HAD EATEN LUNCH WITHIN 30 MINUTES OF CALL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6465059 ↗