BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1933793 · Received December 8, 2010

    Report

    Report Number
    2183996-2010-02553
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 THAT ON (B)(6) 2010, HE BOLUSED FOR DINNER AND 1-1.5 HOURS LATER, HIS BLOOD GLUCOSE MEASURED 408 MG/DL. HE BOLUSED 10 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. ONE HOUR LATER, HIS BLOOD GLUCOSE MEASURED 371 MG/DL AND APPROX ONE HOUR LATER WAS MORE ELEVATED. HE DISCONNECTED FROM THE INFUSION SET AND BOLUSED AND NO INSULIN EMERGED. HE REMOVED THE TRANSFER SET FROM THE INFUSION TUBING AND INSULIN FLOWED OUT. HE CHANGED THE INFUSION SET AND BOLUSED TO LOWER HIS BLOOD GLUCOSE. HE STATED E4 (OCCLUSION) WAS NOT PROPERLY DISPLAYED ON THE INFUSION DEVICE. HIS NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. HE STATED THAT HE REUSES INSULIN CARTRIDGES 2-3 TIMES AND HE WAS ADVISED PER THE USER GUIDE. NO FURTHER INFO IS AVAILABLE. 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention INSULIN INFUSION SET| INSULIN