BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982048 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00190
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 28, 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
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO A MISHANDLING OF THE PRODUCT. E8 (POWER INTERRUPT) WERE FOUND IN THE HISTORY. THE DOWN BUTTON IS ALWAYS ACTIVE. DUE TO AN EXTERNAL MECHANICAL INFLUENCE THE SNAP DOME OF THE DOWN BUTTON IS PRESSED THROUGH. THIS SOURCE LED TO AN ALWAYS ACTIVATED DOWN BUTTON AND UNCLEARABLE E8 ERROR MESSAGES.

    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 REPORTED THE INFUSION DEVICE DISPLAYED AN E8 POWER INTERRUPT ERROR AFTER THE BATTERY WAS CHANGED, AND THE ERROR COULD NOT BE CLEARED BY PRESSING THE CHECK BUTTON. THE INFUSION DEVICE WAS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55277 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

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