TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter (REF RE4002-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00096295126600), received between Jan 11, 2017 and Nov 16, 2018 — classified as 17 malfunctions.

The most frequently reported specific device problem is “High Test Results” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. 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 NON-FASTING BY CUSTOMER AND PRODUCED TEST RESULTS OF 564 AND 521MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/31/2020 AND OPEN VIAL DATE IS 10/18/18. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (DATE/TIME NOT STORED CORRECTLY) RESULT 1:HI DISPLAY DATE:(B)(6) 2018, TIME:1:33PM FASTING, RESULT 2:380MG/DL DATE:(B)(6) 2017, TIME:8:21PM FASTING, RESULT 3: HI DISPLAY DATE:(B)(6) 2017, TIME:1:17PM FASTING, RESULT 4:302MG/DL DATE:(B)(6) 2018, TIME:8:55PM FASTING, RESULT 5:498MG/DL DATE:(B)(6) 2018, TIME:10:01AM N/FASTING. CUSTOMER IS CONCERNED WITH HI DISPLAY RESULTS ON TWO OCCASIONS. CUSTOMER IS NOT CONCERNED WITH OTHER READINGS AND STATES HE IS ALWAYS READING HIGH. CUSTOMER STATES HE MISSED HIS PILL ON SATURDAY AND SUNDAY NIGHT. CUSTOMER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8077855 ↗
• MalfunctionAug 13, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS REPORTED OF 145, 131 AND 177 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 105 MG/DL. CUSTOMER WAS NOT USING CORRECT TESTING TECHNIQUE FOR BACK TO BACK TEST. AT THE TIME OF THE CALL THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. WHEN CUSTOMER HAD OBTAINED THE RESULTS OF CONCERN, SHE REPORTED SHE HAD SYMPTOMS OF DIZZINESS AND FREQUENT URINATION. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. 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. TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 07/17/2019 AND OPEN VIAL DATE IS THREE WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (TIME / DATE NOT SET): (B)(6). CUSTOMER IS GETTING ERRATIC READINGS AND 2 DAYS AGO SHE HAD GOTTEN HIGH READINGS, AND WAS SUFFERING FROM SYMPTOMS OF HIGH BLOOD GLUCOSE, AND HAD FELT ILL, WAS DIZZY AND HAD FREQUENT URINATION. CUSTOMER DID N

  Patient problems: Dizziness; Urinary Frequency / Polyuria

  MAUDE report 7776925 ↗
• MalfunctionJul 24, 2018Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER 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 WHEN THE TEST STRIP WAS INSERTED INTO THE TRUEMETRIX METER. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING CLAMMY AND HAVING BLURRY VISION AND LOW ENERGY. CUSTOMER DID NOT NEED MEDICAL ATTENTION AT THE TIME OF THE CALL. CUSTOMER WAS USING PROPER TESTING TECHNIQUE. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2019 AND OPEN VIAL DATE WAS UNDISCLOSED. TEST STRIPS ARE STORED IN THE ORIGINAL CONTAINER. THREE NIGHTS AGO CUSTOMER DID LEAVE THE VIAL CAP OPEN FOR THE WHOLE NIGHT. CUSTOMER WAS ADVISED TO PURCHASE NEW TEST STRIPS. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER.

  Patient problems: Blurred Vision; Fatigue

  MAUDE report 7715048 ↗
• 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 115 -116 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. THE TEST STRIP MANUFACTURER'S EXPIRATION DATE IS 07/25/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1:328 MG/DL, DATE:(B)(6) 2018, TIME:02:14 PM, FASTING; RESULT 2:232 MG/DL, DATE:(B)(6) 2018, TIME:03:49 PM, FASTING; RESULT 3:241 MG/DL, DATE:(B)(6) 2018, TIME:11:02 PM, FASTING; RESULT 4:143 MG/DL, DATE:(B)(6) 2018, TIME:08:52 AM, FASTING; RESULT 5:249 MG/DL, DATE:(B)(6) 2018, TIME:09:20 PM, FASTING. THE CUSTOMER IS STATING THAT WHEN HE COMPARES THE RESULTS FROM HIS METER TO HIS PHYSICIAN'S METER (AT SCHEDULED ROUTINE VISIT) IT IS READING 100 POINTS DIFFERENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7512736 ↗
• MalfunctionApr 20, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULTS. SON IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID NOT REPORT 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 BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/14/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CALLER WANTED TO KNOW WHAT A E-5 MEANT BECAUSE SHE TESTED ABOUT 7 TIMES AND GOT A READING OF E-5 BETWEEN 2 VIALS OF STRIPS BOTH OF THE SAME LOT NUMBER. CALLER WAS TOLD THAT ERROR COULD MEAN A TEST STRIP ERROR OR THAT SHE IS EXCEEDING 600 MG/DL. THE CUSTOMER STATED THAT SHE DID NOT FEEL ANY HYPERGLYCEMIC SYMPTOMS AND THAT SHE FELT FINE. SON WAS ASKED TO HAVE HER TEST AGAIN WITH A NEW VIAL OF STRIPS AND SHE GOT A READING OF E-5 AGAIN (SAME LOT NUMBER AS THE FIRST. SON WAS ASKED IF THERE WERE ANY OTHER VIALS IN THE HOME WITH A DIFFERENT LOT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7448317 ↗
• MalfunctionApr 6, 2018High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-1 ACCOMPANIED BY HI AND SYMPTOMS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF FATIGUE. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS NOT STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN EXTREME COLD TEMPERATURE. DURING THE CALL ON (B)(6) 2018, A BLOOD TEST WAS PERFORMED FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF HI USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Fatigue; Hyperglycemia

  MAUDE report 7402510 ↗
• MalfunctionJan 12, 2018Incorrect 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 BLOOD TESTS OF 87, 162 AND 151 MG/DL. THE CUSTOMER IS ALSO CONCERNED THAT THE RESULTS OF 162 AND 151 MG/DL ARE HIGH AND THAT THE RESULT OF 87 MG/DL IS LOW. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-120 MG/DL. CUSTOMER STATED HIS A1C IS 12 AND THAT HIS DIABETES WAS DISCOVERED A MONTH AGO; CUSTOMER STATED HE BEGAN MEDICATION AND NOW HIS RESULTS HAVE BEEN BETTER. 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 CUSTOMER IS STORING HIS STRIPS IN LIVING AREA WHERE A FURNACE IS BEING USED TO WARM THE HOUSE DUE TO COLD WEATHER. CUSTOMER WAS ADVISED OF PROPER STORAGE TECHNIQUE AND TO DISCONTINUE USE OF ALCOHOL. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/25/2019 AND OPEN VIAL DATE AT TIME OF CALL IS SIX WEEKS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7185852 ↗
• MalfunctionJan 8, 2018High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI READING. RECEPTIONIST IS CALLING ON BEHALF OF THE CUSTOMER WHO IS ALSO PRESENT. THE CUSTOMER IS CONCERNED WITH RESULTS OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER FEELS WELL AND DID/ DID NOT REPORT SYMPTOMS. 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) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/18/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER REFUSED TO CONTINUE TROUBLE SHOOTING. CALLED ENDED AFTER THE CUSTOMER STATES THAT HE WILL CALLED HIS DOCTOR. CUSTOMER SATES HE FEELS WELL BUT HIS BLOOD SUGAR RUNS IN THE 800MG/DL. EXPLAINED TO CUSTOMER THAT A HI MEANS THAT HIS BLOOD SUGAR MAY BE OVER 600MG/DL. CUSTOMER IS NEWLY DIAGNOSE, CUSTOMER STATED THAT WITH OTHER PRODUCTS HIS BLOOD SUGAR HAS RUN OVER 800MG/DL, HE WANTED TO KNOW WHAT DOES A HI MEANS BECAUSE THE TRUE METRIX METER READ HI. CUSTOMER REFUSED TO CONTINUE TROUBLESHOOTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7173226 ↗
• MalfunctionDec 19, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS. THE CUSTOMER IS CONCERNED WITH RESULTS OF 160, 218 AND 212 MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80-130 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. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/28/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATES THE METER IS READING HIGH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130140 ↗
• MalfunctionOct 26, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE RESULT. DIANE, WIFE, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH RESULTS OBTAINED OF HI. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-150MG/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 IS STORED BY CUSTOMER ACCORDING TO SPECIFICATION IN THE OFFICE. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS PERFORMED NON-FASTING BY THE CUSTOMER AND PRODUCED TEST RESULTS OF 587 AND 539MG/DL USING TRUE METRIX METER. 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 : 578MG/DL DATE: (B)(6) 2017 TIME: 7:02 PM NON-FASTING. RESULT 2 : HI DATE: (B)(6) 2017 TIME: 5:52PM FASTING. RESULT 3 : HI DATE: (B)(6) 2017 TIME: 12:50PM UNCERTAIN. RESULT 4 : HI DATE: (B)(6) 2017 TIME: 4:40PM FASTING. RESULT 5 : HI DATE: (B)(6) 2017 TIME: 11:21AM NON-FASTING. CUSTOMER CALLED IN STATES THE METER IS READING HI. AT THE TIME OF THE BACK TO BACK READINGS THE CUSTOMER TOOK 10 UNITS OF INSULIN (HUMALOG)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6981186 ↗
• MalfunctionOct 18, 2017High Test Results; High Test Results

  DURING FOLLOW UP CALL MADE ON (B)(6) 2017 FOR INTERNAL REPORT (B)(4), THE CONSUMER REPORTED COMPLAINT AND MEDICAL ATTENTION RECEIVED DUE TO HI BLOOD GLUCOSE TEST RESULTS USING TRUEMETRIX METER. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 120 MG/DL. AT THE TIME OF THE CALL THE CUSTOMER STATED HE HAD FREQUENT URINATION; CUSTOMER DENIED THE NEED FOR MEDICAL ATTENTION AT THE TIME OF THE CALL. CUSTOMER STATED THAT ON (B)(6) 2017 HE OBTAINED A RESULT OF HI USING THE TRUEMETRIX METER AND WENT TO THE HOSPITAL DUE TO THE HI RESULT OBTAINED. THE HOSPITAL'S DIAGNOSIS WAS HYPERGLYCEMIA. THE CUSTOMER RECEIVED IV FLUIDS AND INSULIN THERAPY UNTIL HIS GLUCOSE LOWERED. THE CUSTOMER'S BLOOD GLUCOSE TEST RESULT WHEN AT THE HOSPITAL WAS 258 MG/DL. THE CUSTOMER LEFT THE HOSPITAL ON (B)(6) 2017. THE CUSTOMER CONTINUED TO USE THE TRUEMETRIX METER. THERE WERE NO NEW MEDICATIONS OR HEALTHCARE PROGRAM SUGGESTED. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 549 MG/DL AND HI USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATIO

  Patient problems: Hyperglycemia

  MAUDE report 6957827 ↗
• MalfunctionJul 20, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE RESULTS ACCOMPANIED BY SYMPTOMS. THE CUSTOMER IS CONCERNED WITH THE NON- FASTING RESULT OF 249MG/DL. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-100MG/DL. THE CUSTOMER DID REPORT SYMPTOM OF HAVING A TERRIBLE HEADACHE. 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 KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/15/2017 AND OPEN VIAL DATE IS 04/29/2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6). CUSTOMER CALLED IN TO REPORT HIGH RESULTS ON HER METER. CUSTOMER STATES SHE HAS A TERRIBLE HEADACHE AND DENIES MEDICAL ATTENTION. CUSTOMER REALIZED THAT THE HIGH RESULT WAS AFTER SHE HAD BREAKFAST BUT STILL BELIEVES IT IS TOO HIGH, EVEN AFTER EATING.

  Patient problems: Headache

  MAUDE report 6728828 ↗
• MalfunctionApr 28, 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 TEST RESULTS FROM RESULTS OBTAINED OF 497 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 125 - 155 MG/DL. CUSTOMER DID NOT HAVE HGA1C INFORMATION. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER REPORTED SYMPTOMS OF BLURRY VISION, THIRSTY AND TIRED. CUSTOMER STATED THE DAY PRIOR TO CALL SHE HAD OBTAINED A RESULT OF 600 MG/DL AND HAD CALLED HER DOCTOR; THE DOCTOR HAD NOT RETURNED HER PHONE CALL. CUSTOMER CALLED HER DOCTOR DURING THE PHONE CALL ON (B)(6) 2017; THE DOCTOR'S NURSE TOLD CUSTOMER THAT SHE WOULD HAVE DOCTOR CALL HER BACK. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/25/2018 AND OPEN VIAL DATE IS (B)(6) 2017. CUSTOMER DID NOT WANT TO GO THROUGH THE METER MEMORY TO OBTAIN OTHER RESULTS, SO BLOOD GLUCOSE OF 497 MG/DL IS ONLY READING: (B)(6). MEMORY CONCERNS:497MG/DL. CUSTOMER WAS COMPLAINING ABOUT HER SUGAR AND SHE WAS NOT COMPLAINING ABOUT THE METER. SHE WANT

  Patient problems: Blurred Vision; Fatigue; No Code Available

  MAUDE report 6529540 ↗
• MalfunctionApr 24, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-3 ERROR: USED TEST STRIP, TEST STRIP OUTSIDE OF VIAL TOO LONG, SAMPLE ON TOP OF TEST STRIP. DAUGHTER IS CALLING ON BEHALF OF THE CUSTOMER. THE E-3 ERROR OCCURRED AS SOON AS THE TEST STRIP WAS INSERTED IN THE METER. THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE WAS UNDISCLOSED. DURING THE CALL ON (B)(6) 2017, THE CUSTOMER WAS EXPERIENCING SHAKINESS. PER DAUGHTER, CUSTOMER DID NOT REQUIRE MEDICAL ATTENTION AT TIME OF CALL. DURING THE CALL ON (B)(6) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF 66 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/25/2018 AND OPEN VIAL DATE AT TIME OF CALL IS TWO WEEKS. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: Shaking/Tremors

  MAUDE report 6515786 ↗
• MalfunctionApr 21, 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 215 MG/DL. THE CUSTOMER'S EXPECTED FASTING BOOD GLUCOSE TEST RESULT RANGE IS 80 TO 130MG/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 STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/13/2018 AND OPEN VIAL DATE IS (B)(6) 2017 THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). MEMORY CONCERNS: CUSTOMER IS CONCERN WITH THE RESULTS TAKEN ON (B)(6) 2017 CUSTOMER HAVE ONLY BEEN USING THE METER FOR A WEEK NOW. CUSTOMER STATES THAT ON (B)(6) 2017 SHE RUN AND GOT A RESULT OF 205MG/DL FASTING THEN SHE DECIDED TO WALK, CAME BACK RUN ANOTHER TEST AND GOT 113MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6511138 ↗
• MalfunctionMar 21, 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 147, 176 AND 161 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 - 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. 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 ON THE KITCHEN TABLE. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 11/30/2017 AND OPEN VIAL DATE IS MONTH OF (B)(6) 2017. CUSTOMER STATED HE TAKES HIS BLOOD TEST FASTING. CUSTOMER STATED HE DOES NOT TAKE ANY MEDICATION FOR HIS DIABETES AND HAS HAD NO CHANGES IN HIS DIET AND EXERCISE. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE/TIME NOT SET): (B)(6). MEMORY CONCERNS:THE CUSTOMER IS CONCERNED WITH THE RESULTS OF 147,176,161, AND 189MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6422435 ↗
• MalfunctionJan 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 TESTS RESULTS FROM RESULTS OBTAINED OF 126 AND 48 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 TO 90 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE BEDROOM. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/30/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER CALLED IN STATING HIS METER WAS READING ERRATIC. CUSTOMER STATES HE IS FEELING PHYSICALLY WELL AT TIME, DENIES HAVING ANY SYMPTOMS OF HIGH OR LOW BLOOD SUGAR, DENIES NEED FOR MEDICAL ATTENTION. CUSTOMER STATES HIS NORMAL RANGE IS 70-90 MG/DL FASTING, CUSTOMER IS ONLY MANAGING HIS DIABETES WITH DIET AND EXERCISE. CUSTOMER HAS NOT HAD ANY RECENT CHANGES IN DIET, EXERCISE, OR MEDICATIONS. CUSTOMER STATES HE IS CONCERNED WITH READINGS OBTAINED (B)(6) 2016 AT 8:40 AM OF 126 MG/DL AND 48 MG/DL. CUSTOMER STATES THAT HE KNOWS THE 48 MG/DL IS NOT CORRECT AS HE WAS NOT EXPERIENCI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6241517 ↗