BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 8042069 · Received November 6, 2018

    Report

    Report Number
    1000113657-2018-01138
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 6, 2018
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006051
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-58-USER HAD AN INACCURATE REFERENCE: SELF: THE PERSON IS USING THEMSELVES AS THE REFERENCE OR HOW THEY FEEL AT THE TIME THEY RUN THE BLOOD TEST. (B)(4). MANUFACTURER CONTACTED CUSTOMER ON (B)(4) 2018 IN A FOLLOW-UP CALL TO ENSURE THAT THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN; CUSTOMER STATED THAT THE REPLACEMENT PRODUCT IS WORKING TO THEIR SATISFACTION AND THEY HAVE NOT HAD ANY MEDICAL INTERVENTION OR SYMPTOMS SINCE THE LAST CALL.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. SCHOOL NURSE (LPN) IS CALLING ON BEHALF OF THE CUSTOMER. THE SCHOOL NURSE IS CONCERNED WITH TESTS RESULTS OF 55 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 230 - 310 MG/DL. SCHOOL NURSE STATED THAT SHE CHECKED THE CUSTOMER'S BLOOD GLUCOSE LEVEL YESTERDAY AND THE RESULT WAS 55 MG/DL FASTING. SCHOOL NURSE STATED THAT SHE HAD PROVIDED THE STUDENT WITH A HIGH CARB SNACK, THEN RE-CHECKED THE BLOOD GLUCOSE LEVEL FIVE MINUTES AFTER AND THE RESULT WAS 184 MG/DL NON-FASTING; SHE CHECKED AGAIN, AND THE RESULT WAS 216 MG/DL NON-FASTING. 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 ON (B)(6) 2018, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO THE SPECIFICATION IN THE MEDICINE CART. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/31/2019 AND OPEN VIAL DATE IS (B)(6) 2018. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882769 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MV2874 00021292006051

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR