TRUE METRIX TRUE METRIX Self Monitoring Blood Glucose Meter (REF RE4078-40)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00021292007614), received between Dec 2, 2016 and Jun 9, 2017 — classified as 8 malfunctions.

The most frequently reported specific device problem is “High Test Results” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 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 380MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 TO 180MG/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. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS DECLINED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 06/20/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): THE 216MG/DL (B)(6) 2017 11:58 AM FASTING: YES, THE 199MG/DL (B)(6) 2017 06:34 PM FASTING: YES, THE 136MG/DL (B)(6) 2017 04:37 PM FASTING: YES, THE 363MG/DL (B)(6) 2017 01:44 PM FASTING: YES, THE 380MG/DL (B)(6) 2017 01:43 PM FASTING: YES. CUSTOMER IS CONCERNED WITH HIGH RESULTS. RESULT OF CONCERN IS 380MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629940 ↗
• MalfunctionJun 8, 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 194MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100 TO 120MG/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 06/20/2018 AND OPEN VIAL DATE IS WITHIN THE MONTH OF (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY. 194MG/DL (B)(6) 2017 07:20 AM FASTING: YES, 155MG/DL (B)(6) 2017 05:00 PM FASTING: YES, 162MG/DL (B)(6) 2017 09:15 AM FASTING: YES, 147MG/DL (B)(6) 2017 07:35 PM FASTING: YES, 192MG/DL (B)(6) 2017 08:00 AM FASTING: YES. CUSTOMER IS CONCERNED WITH HIGH READINGS. RESULT OF CONCERN IS 194MG/DL FASTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6622263 ↗
• MalfunctionJun 1, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR E-0 WITH SYMPTOMS. (B)(6), WIFE, IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM (RESULTS OBTAINED OF E-0 AND SYMPTOMS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 290 TO 350MG/DL. THE CUSTOMER DID REPORT SYMPTOMS OF DIZZINESS. MEDICAL ATTENTION IS 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) 2017, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 350MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/22/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. CUSTOMER'S WIFE CALLED IN REPORTING E-0 ON HER HUSBAND'S METER. CUSTOMER JUST WOKE UP FROM A NAP AND FELT DIZZY. CUSTOMER DENIES THE NEED FOR MEDICAL ATTENTION. CALLER STATED THAT SHE SPOKE TO PHYSICIAN ABOUT ERROR MESSAGES AND THE PHYSICIAN REQUESTED A CALL ONCE CUSTOMER WAS ABLE TO OBTAIN A READING. CUSTOMER WAS USING LANCING DEVICE ON POSITION 1 AND HAD TO SQUEEZE HIS FINGER TO OBTAIN AN AMPLE SIZE OF BLOOD. INS

  Patient problems: Dizziness; Hyperglycemia

  MAUDE report 6606458 ↗
• MalfunctionApr 25, 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 205, 239 AND 217 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90 - 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 NON-FASTING AND PRODUCED TEST RESULTS OF 190 MG/DL AND 187 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 05/14/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: THE 205MG/DL (B)(6) 2017 01:17 PM FASTING: YES, THE 239MG/DL (B)(6) 2017 12:33 PM FASTING: YES, THE 217MG/DL (B)(6) 2017 11:05 AM FASTING: YES, THE 163MG/DL (B)(6) 2017 09:43 PM FASTING: YES, THE 213MG/DL (B)(6) 2017 08:35 PM FASTING: YES. MEMORY CONCERNS: CUSTOMER IS CONCERNED ABOUT ALL OF THESE READINGS CUSTOMER IS CALLING CONCERNING HIGH RESULTS. CUSTOMER SAYS THAT SHE COMPARED RESULTS ON METER TO RESULTS ON DOCTOR'S METER

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6520038 ↗
• MalfunctionMar 16, 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 152 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 70 TO 80MG/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. DURING THE CALL ON 02/21/2017, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 140 AND 141MG/DL USING TRUE METRIX METER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/29/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(4). CUSTOMER DENIED THE NEED OF MEDICAL ATTENTION. CUSTOMER DENIED OF SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. NO CHANGES IN DIET OR MEDICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6411576 ↗
• MalfunctionDec 28, 2016Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CONSUMER REPORTED COMPLAINT FOR ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER CALLED INITIALLY FOR AN E-3 ERROR MESSAGE BUT WHEN CUSTOMER OBTAINED A RESULT OF 397 MG/DL FROM BLOOD TEST DONE DURING CALL, SHE STATED THAT IT WAS TOO HIGH COMPARED TO THE RESULT OF 144 MG/DL SHE RECEIVED 20 MINS AGO THAT WAS ALSO FASTING. 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) 2016, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 397 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/31/2017 AND OPEN VIAL DATE IS (B)(6) 2016. THE CUSTOMER STATED SHE IS ON INSULIN. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: 397 273 200 162MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6209109 ↗
• MalfunctionDec 21, 2016Incorrect 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 FROM BACK TO BACK BLOOD TESTS OF 231 AND 91 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 120 MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL ON (B)(6) 2016, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 175 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/29/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS:91 AND 231 MG/DL

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6196254 ↗
• MalfunctionDec 2, 2016High Test Results; High Test Results

  COSTUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM ALL OF THE RESULTS OBTAINED. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 135 TO 150MG/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) 2016, A BACK TO BACK BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULTS OF 328 AND 375MG/DL . THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 01/31/2018 AND OPEN VIAL DATE IS (B)(6) 2016. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). MEMORY CONCERNS: HIGH RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6142292 ↗