BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3223620 · Received July 12, 2013

    Report

    Report Number
    2183996-2013-01282
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 7, 2013
    Report Date
    September 6, 2013
    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
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - THE COMPLAINT CANNOT BE VERIFIED DUE TO A CARELESS HANDLING OF THE PRODUCT. RESULT THE SOFTCOMPONENTS OF THE UP/DOWN BUTTON ARE LACERATED. THE DAMAGES DID NOT INFLUENCE THE FUNCTIONALITY OF THE INSULIN PUMP. INGRESS OF LIQUID CAN BE POSSIBLE. THE BUTTONS WERE TESTED SUCCESSFULLY AND THE FUNCTIONALITY COMPLY WITH THE PRODUCT SPECIFICATION. THE PROBLEM MENTIONED BY THE CUSTOMER IS RELATED TO CARELESS HANDLING OF THE PRODUCT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT REPORTED THAT ALL OF THE BUTTONS ON THE INFUSION DEVICE ARE NON- FUNCTIONAL. PATIENT DID NOT REPORT ANY HEALTH CONCERNS. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322623 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 040 YR