BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2110230 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01461
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    March 27, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THE UP BUTTON ON THE INFUSION DEVICE IS NOT RESPONDING TO PRESS. PT STATED SHE ATTEMPTED TO BOLUS AND THE UP BUTTON DID NOT WORK. PT REPORTED SHE SWITCHED TO HER BACKUP INFUSION DEVICE. PT STATED THE CONCERN OCCURRED ABOUT A MONTH AGO. PT REPORTED THE BUTTON DOES NOT REMAIN FLAT WHEN PRESSED. 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 63 YR INSULIN INFUSION SET| INSULIN