BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9946203 · Received April 9, 2020

    Report

    Report Number
    1000113657-2020-00220
    Event Type
    Malfunction
    Date Received
    April 9, 2020
    Date of Event
    March 13, 2020
    Report Date
    May 21, 2020
    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

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 21-MAY-2020: H6: UPDATED FDA'S METHOD, RESULT, AND CONCLUSION CODES. 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 STRIP LOT TESTED AND PASSED.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58: USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND CUSTOMER DECLINED TO GO TO HER POST OFFICE TO PICK UP THE REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR E-3 ERROR CODE AND FOR HI BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF HI. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 98-118 MG/DL; EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 200-221 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 BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 260 MG/DL USING TRUEMETRIX METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 11/30/2020 AND OPEN VIAL DATE IS (B)(6) 2020. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410679 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL MW3337S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1