BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811132 · Received August 13, 2010

    Report

    Report Number
    2183996-2010-01599
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 29, 2010
    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 THAT ON (B)(6) 2010, HE FELT VERY SICK AND HAD IMPAIRED VISION AND HIS BLOOD GLUCOSE MEASURED "HI" ON HIS BLOOD GLUCOSE MONITOR. HE PLACED THE INFUSION DEVICE IN THE STOP MODE AND THEN E4 (OCCLUSION) ERROR WAS DISPLAYED. HE BELIEVES THE ERROR WAS DISPLAYED TOO LATE. HE CHANGED THE INFUSION SITE AND PROGRAMMED A 200% TEMPORARY BASAL RATE INCREASE AND BOLUSED 18 UNITS OF INSULIN. AT 1:30PM HIS BLOOD GLUCOSE MEASURED 457 MG/DL AND HE BOLUSED 10 UNITS OF INSULIN, AT 2.30PM HIS BLOOD GLUCOSE MEASURED 197 MG/DL AND HE BOLUSED 6 UNITS OF INSULIN, AND AT 6:15PM HIS BLOOD GLUCOSE MEASURED 102 MG/DL. 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 69 YR INSULIN INFUSION SET| INSULIN