BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2202462 · Received August 5, 2011

    Report

    Report Number
    2183996-2011-02170
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 25, 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 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

    PT REPORTED PUTTING A NEW INSULIN CARTRIDGE IN HER INFUSION DEVICE AND WENT TO BED. PT STATED THE NEXT MORNING SHE WOKE UP WITH A BLOOD GLUCOSE LEVEL OF 690 MG/DL AND HAD TO BE TAKEN IMMEDIATELY TO THE HOSP. TREATMENT RECEIVED WAS NOT PROVIDED. LENGTH OF TIME IN THE HOSP WAS NOT PROVIDED. PT REPORTED THE INSULIN CARTRIDGE IN THE INFUSION DEVICE WAS EMPTY, THE PISTON ROD OF THE INFUSION DEVICE WAS IN THE MIDDLE POSITION, AND THE RUBBER WORK IN THE INSULIN CARTRIDGE WAS IN THE MIDDLE POSITION; NO ERROR MESSAGE WAS DISPLAYED. PT STATED THE INFUSION DEVICE DIDN'T GET WET AND THE INSIDE OF THE DEVICE IS DRY. PT REPORTED SHE DID NOT GET HER INSULIN IN THE NIGHT. NO FURTHER INFO IS AVAILABLE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE 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 Hospitalization| R INSULIN INFUSION SET| INSULIN