BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 10825321 · Received November 11, 2020

    Report

    Report Number
    1000113657-2020-00831
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 20, 2020
    Report Date
    December 16, 2020
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292008642
    PMA / PMN Number
    K032657
    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 16-DEC-2020: METER WAS RETURNED FOR EVALUATION; NO DEFECT WAS DETECTED. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-020 USER'S TEST STRIP HAD POOR STORAGE.

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). PRODUCTS WERE RETURNED AND PENDING QC EVALUATION. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 02-NOV-2020 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - ABLE TO ESTABLISH CONTACT WITH CUSTOMER AND STATED REPLACEMENT PRODUCT RESOLVED INITIAL CONCERN.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 221, 204, 279 AND 298 MG/DL FASTING AND RESULT OBTAINED OF 389 MG/DL NON-FASTING. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT IS 150 MG/DL; EXPECTED NON-FASTING BLOOD GLUCOSE TEST RESULTS WERE NOT PROVIDED. CUSTOMER WAS NOT USING THE PROPER TESTING TECHNIQUE. 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. CUSTOMER CARRIES THE TRUETRACK METER AND TEST STRIPS AROUND IN A BRIEFCASE AND KEEPS THEM ON THE KITCHEN TABLE WHEN NOT IN USE. 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
    1289898 TRUETRACK SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, SUNMARK MEDI MEDI50CT TT RW5335 00021292008642

    Patients

    Seq Age Sex Outcome Treatment
    1