BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE METRIX

    MDR report key: 9403392 · Received December 3, 2019

    Report

    Report Number
    1000113657-2019-10196
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 3, 2019
    Manufacturer
    TRIVIDIA HEALTH INC
    Product Code
    NBW
    UDI-DI
    00021292007836
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT REFERENCE NUMBER: (B)(4). METER WAS RETURNED FOR EVALUATION. NO DEFECT WAS DETECTED. TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-12: PRODUCT EXPIRED. NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS OBTAINED OF 289, 242, 209, 233 AND 438 MG/DL. CUSTOMER ALSO STATED THAT HE HAD OBTAINED RESULTS OF 600 MG/DL AND THEN 400 MG/DL; IT WAS NOT KNOWN IF THESE RESULTS WERE FASTING OR NON-FASTING. THE CUSTOMER¿S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 80 - 160 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 PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LIVING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 07/26/2019 (EXPIRED), AND CUSTOMER DID NOT RECALL THE OPEN VIAL DATE. CUSTOMER HAD ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY, LOT NUMBER MW3518S, MANUFACTURER'S EXPIRATION DATE OF 03/20/2021. THE CUSTOMER DECLINED TO PERFORM A BACK TO BACK BLOOD TEST DURING THE CALL. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: RESULT 1: 289MG/DL DATE: 11/6/2019 TIME: 12:47PM FASTING, RESULT 2: 242MG/DL DATE: 11/6/2019 TIME: 2:50PM FASTING, RESULT 3: 209MG/DL DATE: 11/5/2019 TIME: 5:40PM FASTING, RESULT 4: 233MG/DL DATE: 11/5/2019 TIME: 5:10PM FASTING, RESULT 5: 438MG/DL DATE: 11/4/2019 TIME: 11:26PM FASTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201228 TRUE METRIX SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER NBW TRIVIDIA HEALTH INC STRIP, TRUE METRIX 50CTMG/DL MV2764 00021292007836

    Patients

    Seq Age Sex Outcome Treatment
    1