BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2800162 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01558
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    August 5, 2012
    Report Date
    October 5, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT REPORTED THE DISPLAY OF THE INFUSION DEVICE IS DAMAGED AND HE IS NOT ABLE TO READ THE INSULIN AMOUNTS. THERE IS A BLACK SPOT THAT RANGES FROM THE MIDDLE OF THE DISPLAY TO THE RIGHT. HE STATED THE DISPLAY BECAME DAMAGED BECAUSE HE CARRIES THE INFUSION DEVICE IN HIS POCKET. 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 58 YR RELATED ACCESSORIES| INSULIN| INSULIN INFUSION PUMP