BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX AIR

    MDR report key: 14634610 · Received June 8, 2022

    Report

    Report Number
    1000113657-2022-00324
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 12, 2022
    Report Date
    July 14, 2022
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K150052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). TEST STRIPS WERE NOT RETURNED FOR EVALUATION. METER WAS RETURNED - PRODUCT EVALUATION IN-PROCESS. 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 14-JUL-2022: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: METER WAS RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND NO DEFECT FOUND. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT TESTED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020: USER'S TEST STRIP HAD POOR STORAGE.

    Description of Event or Problem · 0

    CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 130, 124, 185, 137 AND 72 MG/DL. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 90-100 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. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 12/29/2022 AND OPEN VIAL DATE IS WAS NOT DISCLOSED. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (KITCHEN). THE CUSTOMER DID HAVE ANOTHER VIAL OF TEST STRIPS, SAME LOT NUMBER, THAT HAD BEEN STORED AND HANDLED CORRECTLY. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 130 MG/DL DATE: (B)(6) 2022 TIME: 8:58 AM FASTING . RESULT 2: 124 MG/DL DATE: (B)(6) 2022 TIME: 8:26 AM FASTING . RESULT 3: 185 MG/DL DATE: (B)(6) 2022 TIME: 8:25 AM FASTING . RESULT 4: 137 MG/DL DATE: (B)(6) 2022 TIME: 7:20 PM FASTING . RESULT 5: 114 MG/DL DATE: (B)(6) 2022 TIME: 6:32 AM FASTING . RESULT 6: 72 MG/DL DATE: (B)(6) 2022 TIME: 6:53 AM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454266 TRUE METRIX AIR SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TMX KGR 50CTMG/DL ZY4401S 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown