BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2896383 · Received December 5, 2012

    Report

    Report Number
    2183996-2012-01922
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 5, 2012
    Report Date
    March 11, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE 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 THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE DISPLAY WINDOW IS SCRATCHED DUE TO A MECHANICAL IMPACT. THEREFORE, THE DISPLAY IS NO LONGER FULLY READABLE IN THE AREA WHERE THERAPY-RELEVANT INFORMATION IS VISIBLE. THE INSULIN PUMP SHOULDN'T BE EXPOSED TO HIGH MECHANICAL FORCES. AS THE PROBLEM REPORTED BY THE CUSTOMER IS RELATED TO A HANDLING ISSUE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE INITIATED.

    Description of Event or Problem · 1

    THE PT REPORTED THAT THE DISPLAY OF THE INFUSION DEVICE IS "GREASY" AND HARDLY READABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 007000066863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN