BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II POWER SUPPLY

    MDR report key: 3896257 · Received June 26, 2014

    Report

    Report Number
    1823260-2014-04699
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THEY PLUGGED IN THE POWER SUPPLY FOR AN INFORM II BASE UNIT AND THAT SPARKS AND FLAMES CAME OUT OF THE POWER SUPPLY AND THE BASE UNIT DID NOT POWER ON. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE DEVICE, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374045 ACCU-CHEK ® INFORM II POWER SUPPLY BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1