BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUE METRIX

    MDR report key: 15709595 · Received November 1, 2022

    Report

    Report Number
    1000113657-2022-00577
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    October 4, 2022
    Report Date
    November 1, 2022
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER (B)(4): INITIAL CUSTOMER CALL. ADVERSE EVENT REPORT IS BEING SUBMITTED DUE TO CUSTOMER SEEKING MEDICAL ATTENTION CUSTOMER RETURNED 1 TEST STRIP AND METER FOR EVALUATION ON (B)(4) ON (B)(6) 2022. REPORTED DEFECT NOT REPRODUCED ON RETURNED METER. PRODUCT EVALUATION HAS BEEN COMPLETED AND MOST LIKELY UNDERLYING ROOT CAUSE SELECTED. : RETENTION STRIPS TESTED WITHIN 6 MONTHS PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-009: USE ERROR CAUSED OR CONTRIBUTED TO EVENT NOTE: 1. CUSTOMER HAD CONTACTED MANUFACTURER ON (B)(6) 2022 TO REPORT THAT THE REPLACEMENT PRODUCT SENT ON (B)(4) HAD NOT RESOLVED THE INITIAL CONCERN. NOTE: 2. CUSTOMER HAD CONTACTED MANUFACTURER ON (B)(6) 2022 REVIEWED THE TESTING TECHNIQUE. CUSTOMER REQUESTING SOME EXTRA TEST STRIP FOR THE STRIPS THEY WAS NOT ABLE TO USE. SENT CUSTOMER COURTESY VIALS OF TEST STRIPS ON (B)(6) 2022, CUSTOMER WILL CONTACT US IF FURTHER ASSISTANCE IS NEEDED. NO FURTHER ACTION IS NEEDED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER CONTACTED MANUFACTURER ON (B)(6) 2022 AS FOLLOW-UP TO ADDITIONAL REPORT REFERENCE NUMBER (B)(4). HUSBAND IS CALLING ON BEHALF OF THE CUSTOMER. CONSUMER REPORTED COMPLAINT FOR ERROR MESSAGES (E-2 AND E-5) AND LOW BLOOD GLUCOSE TEST RESULTS WITH TEST STRIP ZA4811S SENT AS REPLACEMENT ON 120174-1. CALLER STATED THAT A FEW DAYS PRIOR HE HAD CONTACTED AMBULANCE DUE TO RESULT HAD BEEN 33 MG/DL AND CUSTOMER WAS "ALMOST IN A COMA." CUSTOMER HAD GONE TO THE HOSPITAL. CALLER STATED THE HOSPITAL HAD TESTED THE TEST STRIPS AND "THE HOSPITAL SAID THE STRIPS ARE NO GOOD." NO FURTHER DETAILS REGARDING THE MEDICAL ATTENTION WAS PROVIDED BY THE CALLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438258 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZA4811S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization