BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4088516 · Received August 13, 2014

    Report

    Report Number
    1052693-2014-00254
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Date of Event
    July 16, 2014
    Report Date
    December 30, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Removal / Correction Number
    Z-0910-22014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = T) (B)(4) THE INVESTIGATION FOUND METER PROGRAMMED IN MMOL/L INSTEAD OF MG/DL. THE ROOT CAUSE IS METER WAS CONFIGURED WITH THE INCORRECT UNIT OF MEASURE. METER SERIAL NUMBER IS INCLUDED ON THE RECALL. PRODUCT CODES UPDATED. CORRECTION OF 510(K):FROM K080641 TO K090495.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT SERIAL NUMBER UNDER RECALL. RECALL NUMBER Z-0910-22014.

    Description of Event or Problem · 1

    METER IS READING IN MMOL/L INSTEAD OF MG/DL. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    METER IS READING IN MMOL/L INSTEAD OF MG/DL. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482460 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR