BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2120314 · Received June 1, 2011

    Report

    Report Number
    2183996-2011-01536
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 6, 2011
    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
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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

    PT WAS HOSPITALIZED ON (B)(6) 2011 AND REPORTED THE INFUSION DEVICE DELIVERED TOO MUCH INSULIN. THE INFUSION DEVICE DISPLAYED E6 MECHANICAL ERROR, AND PT CHANGED THE INFUSION SET AND BATTERY TO CLEAR THE ERROR MESSAGE. PT REPORTED THE INFUSION DEVICE THEN, WITHOUT A SIGNAL OR ERROR MESSAGE, DELIVERED TOO MUCH INSULIN. BLOOD GLUCOSE WAS 28 MG/DL, AND PT WAS UNCONSCIOUS. THIS OCCURRED AT APPROX 3:30 P.M. PT WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE. HE WAS TREATED WITH A GLUCOSE SOLUTION AND HOSPITALIZED FOR 1 DAY IN A "PRE-COMA" STATUS. PT DOES NOT KNOW HOW MUCH INSULIN WAS DELIVERED, AND HE WAS NOT WEARING THE INFUSION DEVICE AT THE TIME OF THE REPORT. INFUSION DEVICE WAS REQUESTED FOR EVALUATION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    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 Hospitalization| R INSULIN: (B)(6)| INSULIN INFUSION SET: (B)(6)