BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT CARTRIDGE

    MDR report key: 2170847 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01899
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 14, 2011
    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, THE INSULIN CARTRIDGE IS OFTEN LEAKY AT THE PLUNGER BETWEEN THE VOLUME OF 150 - 200 UNITS OF INSULIN AND HIS BLOOD GLUCOSE IS SOMETIMES ELEVATED TO 300 - 350 MG/DL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INSULIN CARTRIDGE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 32404020

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR INSULIN| INSULIN INFUSION PUMP| INSULIN INFUSION SET