BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2110262 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01432
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HER INFUSION DEVICE IS NOT WORKING. PT STATED SHE ATTEMPTED TO CHANGE HER INSULIN CARTRIDGE YESTERDAY AND INSULIN SPILLED. PT STATED SHE IS NOT SURE HOW IT HAPPENED, BUT WHEN SHE INSERTED THE CARTRIDGE, INSULIN STARTED LEAKING OUT OF THE BOTTOM. PT REPORTED SHE THINKS "SHE MAY HAVE PUNCTURED THE CARTRIDGE WHEN SHE INSERTED IT IN THE PUMP." PT NO LONGER HAS THE ALLEGED INSULIN CARTRIDGE. PT STATED SHE DOESN'T THINK THE PLUNGER WAS SEPARATED FROM THE INSULIN CARTRIDGE. PT REPORTED SHE WAS ABLE TO POUR OUT INSULIN FROM THE INFUSION DEVICE AND ATTEMPTED TO LET IT DRY. PT STATED ONCE THE INSULIN WAS SPILLED IN THE INFUSION DEVICE, THE SCREEN WAS ACTING FUNNY AND "IT KEPT BLANKING OUT." PT REPORTED SHE WOULD TRY TO START THE INFUSION DEVICE, BUT IT WOULDN'T LET HER. PT STATED THE UP AND DOWN BUTTONS WEREN'T FUNCTIONING AFTER THE INSULIN WAS SPILLED. PT REPORTED SHE LET THE INFUSION DEVICE DRY OVERNIGHT BUT IT STILL WASN'T WORKING THIS MORNING. ASSISTED PT WITH SETTING UP BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION DEVICE WAS REPLACED AND REQUESTED RETURN OF THE INFUSION DEVICE 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 43 YR INSULIN INFUSION SET| INSULIN