BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM BASE

    MDR report key: 2010435 · Received March 8, 2011

    Report

    Report Number
    1823260-2011-01230
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 18, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    MANUFACTURER'S INVESTIGATIONAL UNIT CONFIRMED MELTED PLASTIC ON THE INFORM BASE UNIT. NO ADVERSE EVENT REPORTED. SUSPECT DEVICE HAS BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® INFORM BASE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1