BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM BASE

    MDR report key: 3133705 · Received May 29, 2013

    Report

    Report Number
    1823260-2013-03216
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) - INFORM METER (B)(6) - INFORM BASE UNIT.

    Description of Event or Problem · 1

    CALLER STATES THAT THE INFORM BASE UNIT SHOWS SIGNS OF AN ELECTRICAL SHORT. CALLER STATES THAT THE CONNECTOR PINS (FIRST AND LAST) ARE BURNED AND THE PLASTIC IS MELTED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234491 ACCU-CHEK ® INFORM BASE BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1