BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2884784 · Received December 3, 2012

    Report

    Report Number
    2183996-2012-01863
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 25, 2012
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    Z-1646-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PT REPORTED THAT THE UP BUTTON OF THE INFUSION DEVICE IS NOT MAKING A CONNECTION. HE NOTICED THE ISSUE A COUPLE OF DAYS AGO. HE STATED THE BUTTON WILL MAKE A CONNECTION IF IT IS PRESSED HARD AND HE MOVES HIS FINGER AROUND. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP