BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2210193 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01970
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT STATED THAT AFTER AN INSULIN CARTRIDGE CHANGE HE PRIMED HIS INFUSION DEVICE, BUT DID NOT SEE INSULIN COME OUT OF THE TUBING. THE PT THEN PRIMED THE INFUSION DEVICE AGAIN AND ONCE HE WAS ABLE TO SEE INSULIN DRIPPING OUT OF THE END OF THE TUBING HE ATTEMPTED TO STOP THE PRIME. THE PT STATED THAT HE WAS UNABLE TO STOP THE PRIME AND TRIED USING ALL BUTTONS ON THE INFUSION DEVICE TO STOP THE PRIME. THE PT WAS ASKED TO PUT THE INFUSION DEVICE IN "STOP MODE" AND TO PRIME THE INFUSION DEVICE AGAIN. THE ISSUE OF NOT BEING ABLE TO END THE PRIME EARLY WAS ABLE TO BE DUPLICATED. THE PT WAS THEN ASKED TO REMOVE THE BATTERY AND REINSERT IT INTO THE INFUSION DEVICE. AFTER DOING THIS THE INFUSION DEVICE FUNCTIONED AS NORMAL AND PRIMING WAS ABLE TO BE STOPPED EARLY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED 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 64 YR INSULIN INFUSION SET| INSULIN