BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEMETRIX

    MDR report key: 7036763 · Received November 16, 2017

    Report

    Report Number
    1000113657-2017-01958
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 24, 2017
    Report Date
    December 14, 2017
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    UDI-DI
    00021292006075
    PMA / PMN Number
    K140100
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL REPORT # (B)(4). RETURNED METER AND RETURNED TEST STRIPS EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). TEST STRIP UDI# (B)(4).

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) (B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: MLC-20-USER'S TEST STRIP HAD POOR STORAGE (KITCHEN). TEST STRIP (B)(4).

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 82 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 122 - 168 MG/DL. NURSE INITIALLY STATED CUSTOMER HAD PERFORMED A BLOOD TEST AND OBTAINED A RESULT OF 28 MG/DL. UPON REVIEW OF THE METER MEMORY, RESULT OF 28 MG/DL WAS NOT CONFIRMED BUT A RESULT OF 82 MG/DL WAS - THE CUSTOMER HAD READ THE RESULTS UPSIDE DOWN. 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) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE IS AT TIME OF CALL IS FORTY-FIVE DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS NOT CONCERN WITH THE HIGH RESULTS IN THE METERS MEMORY.

    Description of Event or Problem · 1

    CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. NURSE IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 82 MG/DL. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 122 - 168 MG/DL. NURSE INITIALLY STATED CUSTOMER HAD PERFORMED A BLOOD TEST AND OBTAINED A RESULT OF 28 MG/DL. UPON REVIEW OF THE METER MEMORY, RESULT OF 28 MG/DL WAS NOT CONFIRMED BUT A RESULT OF 82 MG/DL WAS - THE CUSTOMER HAD READ THE RESULTS UPSIDE DOWN. 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) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION AND IS STORED IN THE KITCHEN. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/31/2018 AND OPEN VIAL DATE IS AT TIME OF CALL IS FORTY-FIVE DAYS. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6). CUSTOMER IS NOT CONCERN WITH THE HIGH RESULTS IN THE METERS MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816707 TRUEMETRIX BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUEMETRIX MU2376 00021292006075

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR