BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 15079041 · Received July 21, 2022

    Report

    Report Number
    1000113657-2022-00408
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 23, 2022
    Report Date
    July 21, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS (3 VIALS) WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED TEST STRIPS: HIGH RESULTS. NO DEFECT FOUND ON RETURNED METER. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS. 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; CUSTOMER STATED THE ISSUE HAS OCCURRED WITH THREE VIALS OF THE SAME LOT NUMBER OF TEST STRIPS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM BACK TO BACK BLOOD TESTS OF 143, 161, 125, 160 AND 184 MG/DL. CUSTOMER WAS ALSO CONCERNED WITH THE RESULTS COMPARED TO ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 100-110 MG/DL AND EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 140-160 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 PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULTS OF 199 MG/DL AND 196 MG/DL USING TRUE METRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN A CLOSET. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/20/2023 AND TEST STRIPS WERE OPENED THE DAY OF THE CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 143 MG/DL DATE: 6/23/2022 TIME: 9:09 AM FASTING; RESULT 2: 161 MG/DL DATE: 6/23/2022 TIME: 9:08 AM FASTING; RESULT 3: 125 MG/DL DATE: 6/23/2022 TIME: 9:07 AM FASTING; RESULT 4: 160 MG/DL DATE: 6/23/2022 TIME: 9:05 AM FASTING; RESULT 5: 184 MG/DL DATE: 6/23/2022 TIME: 9:04 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561358 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 100CTMG/DL ZA4739S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown