BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2896223 · Received December 7, 2012

    Report

    Report Number
    2183996-2012-01936
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    May 1, 2012
    Report Date
    December 4, 2012
    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
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED THE PROTECTIVE RUBBER ON THE UP AND DOWN BUTTONS HAS PEELED OFF AND THIS HAS CAUSED THE UP AND DOWN BUTTONS TO WORK INTERMITTENTLY. THE BASE-PLATE OF THE INFUSION DEVICE IS VISIBLE. THE FIRST BEGAN IN (B)(6) 2012, AND THE BUTTONS HAVE CONTINUED TO WORK INTERMITTENTLY IF PRESSED HARD. THE BUTTONS ARE NOT FLAT, AND THE INFUSION DEVICE WAS NOT DROPPED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    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 59 YR INSULIN INFUSION PUMP| INSULIN| AND RELATED ACCESSORIES