BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE

    MDR report key: 2148964 · Received June 28, 2011

    Report

    Report Number
    MW5021213
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ROCHE
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S GLUCOSE READING ON THE GLUCOMETER WAS 513. TREATED WITH INSULIN. SUBSEQUENT READINGS OF 183 AND 148. ORIGINAL READING WAS INCORRECT. REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE GLUCOMETER NBW ROCHE 03035123971 UJ32020431

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR