BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2210192 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01971
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    February 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, PT REPORTED THE CHECK BUTTON ON THE INFUSION DEVICE IS NOT WORKING CORRECTLY. PT STATED SHE HAS TO PRESS REALLY HARD ON THE BUTTON FOR IT TO RETURN THE PISTON ROD ON THE DEVICE. PT REPORTED THE CHECK BUTTON WORKS CORRECTLY EVERY OTHER TIME IT IS USED. PT STATED EVEN WHEN PRIMING THE DEVICE, SHE DOES NOT HAVE TO PRESS DOWN REALLY HARD TO START THE PRIME. HAD PT GO THROUGH THE CHANGE THE CARTRIDGE PROCESS AND USE NORMAL PRESSURE TO HOLD THE CHECK BUTTON UNTIL IT SAID RETURNING PISTON ROD; PISTON ROD DID NOT START RETURNING. PT REPORTED THE BUTTON IS RAISED BUT THE BUTTON DOES NOT MAKE A CLICKING SOUND. PT STATED THE CHECK BUTTON HAS NOT WORKED FOR ABOUT 3-4 MONTHS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 49 YR INSULIN INFUSION SET| INSULIN