BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 13841185 · Received March 21, 2022

    Report

    Report Number
    1000113657-2022-00151
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    February 22, 2022
    Report Date
    April 27, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: 106098-1. METER AND TEST STRIPS WERE NOT RETURNED FOR EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON (B)(6) 2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN -ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    Additional Manufacturer Narrative · 0

    SECTIONS WITH ADDITIONAL INFORMATION AS OF 27-APR-2022: D9: DEVICE AVAILABLE FOR EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-018: USER HAS HIGH GLUCOSE VALUE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HI, HIGH AND ERRATIC BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI, 114, 127, 115, 480MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 60-90MG/DL AND EXPECTED ONE HOUR POST MEAL EXPECTED BLOOD GLUCOSE TEST RESULT RANGE IS 100-130MG/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 139MG/DL AND 140MG/DL USING TRUE METRIX METER.; THE CUSTOMER WAS SATISFIED WITH THE RESULTS OBTAINED. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM/LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS (B)(6) 2023 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY:RESULT 1: 114MG/DL DATE: (B)(6) 2022 TIME: 8:06 PM 1 HR. AFTER MEAL. RESULT 2: 127MG/DL DATE: (B)(6) 2022 TIME: 8:04 PM 1 HR. AFTER MEAL.RESULT 3: 115MG/DL DATE: (B)(6) 2022 TIME: 1:32 PM 1 HR. AFTER MEAL.RESULT 4: 480MG/DL DATE: (B)(6) 2022 TIME: 7:31 AM FASTING.RESULT 5: HI MG/DL DATE: (B)(6) 2022 TIME: 7:30 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264577 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX WGN 100CT12/CS MG/DL #383569 ZY4479S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown