BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2943035 · Received January 18, 2013

    Report

    Report Number
    2183996-2012-02197
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT 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 EVALUATION. EVALUATION OF THE DEVICE FOUND THAT THE UP/DOWN BUTTON WAS DEFECTIVE. DURING A TELECONFERENCE ((B)(6) 2012) WITH PERSONNEL FROM (B)(6), A REQUEST WAS MADE TO SUBMIT MEDWATCH REPORTS FOR ALL OUS COMPLAINTS RELATED TO THE ACCU-CHEK SPIRIT RECALL ((B)(4)) RECEIVED AFTER CLOSURE OF THE RECALL ON (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28513 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. 00700006862 NA

    Patients

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