BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2142900 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01886
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 9, 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
    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'S DIET COUNSELOR REPORTED THAT SHE BELIEVES THE PT'S INFUSION DEVICE DELIVERS TOO LITTLE INSULIN. ON (B)(6) 2011 AT 8:00AM, THE PT'S BLOOD GLUCOSE MEASURED 120MG/DL AND HE ATE AND BOLUSED 12 UNITS OF INSULIN THROUGH THE INFUSION DEVICE. AT 12:30PM, THE PT'S BLOOD GLUCOSE MEASURED 250 MG/DL, AT 4:00PM MEASURED 460MG/DL, AND AT 6:00PM MEASURED OVER 500 MG/DL. ON (B)(6) 2011, THE PT'S BLOOD GLUCOSE MEASURED 600 MG/DL AND HE WENT TO THE DIET COUNSELOR WHO INJECTED 6 UNITS OF INSULIN. THE PT DRANK 2 LITERS OF WATER AND AT 3:00PM HIS BLOOD GLUCOSE MEASURED 880 MG/DL. THE DIET COUNSELOR CALLED AN AMBULANCE AND THE PT WAS TRANSPORTED TO THE HOSPITAL AND RELEASED ON (B)(6) 2011. HIS BLOOD GLUCOSE IS NOW IN THE 421 MG/DL RANGE AND HE FEELS GOOD AND IS INJECTING INSULIN VIA SYRINGE. HIS NORMAL BLOOD GLUCOSE LEVEL IS 120 MG/DL. THE INFUSION DEVICE WAS 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 75 YR Hospitalization| O| R (DATE OF TX (B)(6))| INSULIN INFUSION SET| INSULIN (DATE OF TX (B)(6))