BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2141074 · Received June 16, 2011

    Report

    Report Number
    2183996-2011-01625
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 13, 2011
    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
    GM
    Reporter Occupation
    UNKNOWN

    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.

    Description of Event or Problem · 1

    THE PT REPORTED THE E4 (OCCLUSION) ERROR IS NOT PROPERLY DISPLAYED ON THE INFUSION DEVICE AND IS EITHER MISSING OR IS DISPLAYED TOO LATE. DURING THE NIGHT OF (B)(6) 2011, THE PT'S BLOOD GLUCOSE ELEVATED TO 520 MG/DL AND SHE BOLUSED THROUGH THE INFUSION DEVICE BUT WAS UNABLE TO LOWER HER BLOOD GLUCOSE. SHE STATED NO INSULIN CAME OUT OF THE INFUSION SET AND NO E4 WAS DISPLAYED. THE PT CHANGED THE INFUSION SET AND BOLUSED THROUGH THE INFUSION DEVICE TO LOWER HER BLOOD GLUCOSE. HER NORMAL BLOOD GLUCOSE RANGE IS 120-160 MG/DL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR INSULIN| INSULIN INFUSION SET