BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2800154 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01587
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    August 8, 2012
    Report Date
    October 11, 2012
    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
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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 THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT INITIALLY REPORTED THERE WAS A BLACK MARK ON THE INFUSION DEVICE DISPLAY AND THE LEGIBILITY OF THE DISPLAY WAS NOT AFFECTED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. A PRELIMINARY EVALUATION REVEALED THE DISPLAY WAS DAMAGED DUE TO A MECHANICAL IMPACT, AND THE BROKEN DISPLAY COULD LEAD TO MISINTERPRETATION OF INSULIN DELIVERY AMOUNTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| RELATED ACCESSORIES| INSULIN| DATE OF THERAPY: UNK