BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 4792506 · Received April 29, 2015

    Report

    Report Number
    1052693-2015-00649
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 1, 2015
    Report Date
    December 30, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Removal / Correction Number
    Z-0909-2014, Z-0910-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = T) (B)(4) METER WAS IN MMOL INSTEAD OF MG/DL. RECALL METER COMPLAINT AND METERS ARE BEING SCRAPPED. THE ROOT CAUSE IS METER WAS CONFIGURED WITH THE WRONG UNIT OF MEASURE. PRODUCT CODES UPDATED. CORRECTION OF 510(K) #: K090495. (B)(4).

    Description of Event or Problem · 1

    METER IS READY 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
    281100 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUBALANCE BS4597

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR