BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 15138038 · Received August 1, 2022

    Report

    Report Number
    1000113657-2022-00421
    Event Type
    Malfunction
    Date Received
    August 1, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 1, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. PRODUCT STRIP LOT NUMBER PROVIDED IN THE COMPLAINT EXPIRED. UNABLE TO PERFORM RETENTION TESTING. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-012: PRODUCT EXPIRED. 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 BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 191, 147, 260 AND 320 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 160-200 MG/DL AND EXPECTED PM NON-FASTING BLOOD GLUCOSE TEST RESULT IS 160 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, 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 04/30/2022 (EXPIRED) AND OPEN VIAL DATE WAS NOT DISCLOSED. 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 : 191 MG/DL, DATE: (B)(6), 2022, TIME: 09:51 PM, NON-FASTING, RESULT 2 : 314 MG/DL DATE: (B)(6) 2022, TIME: 06:27 AM FASTING, RESULT 3 : 147 MG/DL DATE: (B)(6) 2022, TIME: 02:22 PM NON-FASTING, RESULT 4 : 260 MG/DL DATE: (B)(6) 2022, TIME: 02:21 PM NON-FASTING AND RESULT 5 : 320 MG/DL DATE: (B)(6) 2022, TIME: 02:26 PM NON-FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2921699 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX CVS 100CT12/CASE MG/DL ZX4127S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown