BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2943091 · Received January 18, 2013

    Report

    Report Number
    2183996-2012-02151
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED AN ISSUE WITH THE UP/DOWN BUTTON OF THE INFUSION DEVICE. NO SERIOUS INJURY WAS REPORTED. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR EVAL. EVAL OF THE DEVICE FOUND THAT THE UP/DOWN BUTTON WAS DEFECTIVE. DURING A TELECONFERENCE ((B)(6) 2012) WITH PERSONNEL FROM THE OSB, A REQUEST WAS MADE TO SUBMIT MEDWATCH REPORTS FOR ALL OUS COMPLAINTS RELATED TO THE ACCU-CHEK SPIRIT RECALL (Z-1646-2009) RECEIVED AFTER CLOSURE OF THE RECALL ON 07/03/2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28426 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC 00700006862 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES