BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 17127824 · Received June 14, 2023

    Report

    Report Number
    1000113657-2023-00323
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 19, 2023
    Report Date
    June 29, 2023
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 29-JUN-2023: H6: UPDATED FDA'S TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS. H10: METER WAS NOT RETURNED FOR EVALUATION. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIPS TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). B2: : ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER CONTACTING DOCTOR DUE TO METER RESULTS. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND ON RETURNED METER. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE. NOTE: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 144, 145, 123, 120, 141 AND 133 MG/DL. CUSTOMER STATED THAT HE AT A SCHEDULED DOCTOR VISIT HE WAS ADVISED THAT HIS BLOOD SUGAR IS GOING UP, AND SO HE GOT THE METER TO TEST. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT DUE TO THE METER RESULTS, HE HAD CONTACTED THE DOCTOR; DOCTOR HAD ADVISED CUSTOMER TO CONTACT THE PHARMACY AND PHARMACY ADVISED HIM TO CONTACT THE MANUFACTURER. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/26/2024 AND OPEN VIAL DATE IS 04/05/2023. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY:RESULT 1: 144 MG/DL DATE: 5/18/2023 TIME: 10:12AM FASTING RESULT 2: 145 MG/DL DATE: 5/18/2023 TIME: 10:11AM FASTING RESULT 3: 123 MG/DL DATE: 5/17/2023 TIME: 10:03AM FASTING RESULT 4: 120 MG/DL DATE: 5/17/2023 TIME: 10:02AM FASTING RESULT 5: 141 MG/DL DATE: 5/16/2023 TIME: 10:18AM FASTING RESULT 6: 133 MG/DL DATE: 5/16/2023 TIME: 10:17AM FASTING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972353 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL ZA4863S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other