BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2172367 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01796
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 31, 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
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT'S WIFE REPORTED THAT FOR THE LAST 2 WEEKS, THEY HAVE NOTICED THAT HE HAS HAD TO PRESS THE BUTTONS ON THE INFUSION DEVICE MORE THAN ONCE TO GET THEM TO MAKE A CONNECTION. WIFE STATED, THE UP ARROW BUTTON ON THE INFUSION DEVICE IS NOT WORKING. WIFE REPORTED, SHE WAS UNSURE IF THE BUTTON POPS BACK UP WHEN PRESSED. WIFE DOES NOT HAVE THE INFUSION DEVICE WITH HER TO TROUBLESHOOT. 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 ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR INSULIN INFUSION SET| INSULIN