BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1853421 · Received September 27, 2010

    Report

    Report Number
    2183996-2010-01995
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1415-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE DOWN BUTTON ON HER INFUSION DEVICE IS NOT WORKING. PATIENT STATED, SHE NOTICED IT ABOUT 1 MONTH AGO. PATIENT REPORTED, THE INFUSION DEVICE HAD BEEN DROPPED BUT IS NOT CRACKED OR DAMAGED. PATIENT STATED, SHE IS CURRENTLY USING THE STANDARD BOLUS FEATURE ON THE INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR INSULIN| INSULIN INFUSION SET