BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2943064 · Received January 18, 2013

    Report

    Report Number
    2183996-2012-02129
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 26, 2012
    Report Date
    March 26, 2013
    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
    HU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED ON (B)(4) 2012. THE SOFTCOMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND DESTROYED THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON DOES NOT RESPOND TO COMMANDS DUE TO AN EXTERNAL MECHANIC DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    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 EVALUATION. EVALUATION OF THE DEVICE FOUND THAT THE UP/DOWN BUTTON WAS DEFECTIVE. DURING A TELECONFERENCE ((B)(4) 2012) WITH PERSONNEL FROM THE OSB, A REQUEST WAS MADE TO SUBMIT MEDWATCH REPORTS FOR ALL OUS COMPLAINTS RELATED TO THE ACCU-CHECK 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
    27758 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. 00700006862 NA

    Patients

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