BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM BASE

    MDR report key: 2212786 · Received August 16, 2011

    Report

    Report Number
    1823260-2011-04363
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE INFORM BASE. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(4) FOR THE INFORM METER.

    Description of Event or Problem · 1

    CALLER STATES THAT THE INFORM BASE MELTED AND SMOKED WHILE DOCKED WITH A METER. THE CALLER STATES THAT THERE WAS SMOKE AND MELTING PLASTIC. CALLER STATES THAT SHE DOCKED THE METER INTO THE BASE WHILE WET WITH BLEACH SOLUTION. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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