BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUE2GO

    MDR report key: 3471898 · Received October 23, 2013

    Report

    Report Number
    1052693-2013-00283
    Event Type
    Other
    Date Received
    October 23, 2013
    Date of Event
    September 20, 2013
    Report Date
    October 23, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED FOR EVALUATION. CUSTOMER DID NOT KNOW WHAT SERIAL NUMBER THE METER WAS OR WHAT LOT NUMBER OF STRIPS WERE USED. CUSTOMER DISCARDED METER/TEST STRIPS AND IS SEEKING REIMBURSEMENT FOR DOCTOR'S VISITS AND LABORATORY WORK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT OF HIGH BLOOD RESULTS. LETTER FROM CUSTOMER STATING THAT THE METER READS 147 MG/DL TO 108 MG/DL AT A HOSPITAL LABORATORY. CUSTOMER APPARENTLY IS NOT A DIABETIC BUT CHECK THEIR GLUCOSE REGULARLY DUE TO RISK IN FAMILY. RESULTS OBTAINED ON FIRST AM TESTING PERFORMED ARE AS FOLLOWS: (B)(6) 163 MG/DL ; (B)(6) 154 MG/DL ; (B)(6) 139 MG/DL; (B)(6) 149 MG/DL. READINGS CAUSED CUSTOMER TO VISIT FAMILY DOCTOR WHO ORDERED LABORATORY WORK . THE RESULT OF 108 MG/DL WAS OBTAINED BY LABORATORY ON (B)(6) AND CUSTOMER STATES THAT THE FIRST AM RESULT PERFORMED ON THE METER GAVE 147 MG/DL. UNK ON HOW MUCH TIME PASSED BETWEEN METER RESULT DRAW AND LABORATORY RESULT DRAW. ERROR GRID ANALYSIS PERFORMED ON THE LABORATORY RESULT AND THE METER RESULT RESULTED IN THE VALUES BEING WITHIN ZONE B. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543144 TRUE2GO BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUE2GO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization