BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 14335971 · Received May 9, 2022

    Report

    Report Number
    1000113657-2022-00266
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    March 17, 2022
    Report Date
    May 5, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER AND TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED TEST STRIPS: HIGH RESULTS. NO DEFECT FOUND ON RETURNED METER. ROOT CAUSE: RC-061: STORAGE OUTSIDE SPECIFICATIONS. MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 28-MAR-2022 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED REPLACEMENT PRODUCTS RESOLVED INITIAL CONCERN.

    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 134, 131, 141, 135 AND 130 MG/DL. CUSTOMER STATED THAT HE HAD OBTAINED THE RESULT OF 134 MG/DL FASTING AND HAD GONE TO A SCHEDULED DOCTOR'S APPOINTMENT, WHERE THEY HAD PERFORMED A BLOOD TEST AND OBTAINED A BLOOD GLUCOSE TEST RESULT OF 84 MG/DL USING THE DR'.S DEVICE. CUSTOMER STATED THE TESTS WERE DONE LESS THAN ONE HOUR APART. CUSTOMER STATED THAT A LAB TEST WAS PERFORMED AND THE RESULT WAS 84 MG/DL. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 85-89 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 (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 04/13/2023 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: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454237 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL ZY4498S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown