BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFERENCE GUIDES

    MDR report key: 2874980 · Received December 16, 2012

    Report

    Report Number
    3008382007-2012-08321
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Report Date
    November 29, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012, THE REPORTER CONTACTED LIFESCAN REPORTING THAT THE ONETOUCH VERIOIQ PATTERN GUIDE LITERATURE WAS DAMAGED BY WATER. THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFERENCE GUIDES GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR