BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811533 · Received August 17, 2010

    Report

    Report Number
    2183996-2010-01622
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    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
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED A LARGE BLACK SPOT ON INFUSION DEVICE DISPLAY SCREEN. THIS SPOT INTERFERES WITH ABILITY TO VIEW INSULIN DELIVERY AMOUNTS. PATIENT DELIVERED A BOLUS EARLIER IN THE DAY, AND THE DISPLAY WAS FINE. PATIENT ATTEMPTED TO VIEW BOLUS HISTORY AND THIS IS WHEN HE NOTICED THE BLACK SPOT. PATIENT REPORTS SPOT IS LOCATED ON LEFT SIDE OF DISPLAY AND LOOKS LIKE "AN INK PEN EXPLODED UNDER THE SCREEN." INFUSION DEVICE IS KEPT IN PROTECTIVE CASE. INFUSION DEVICE HAS NOT BEEN DROPPED OR DAMAGED. INFUSION DEVICE HAS NOT BEEN EXPOSED TO WATER OR INSULIN INGRESS. PATIENT IS USING THE CORRECT TYPE OF BATTERY. PATIENT REPORTED THE RUBBER CASING NEAR BUTTON ON INFUSION DEVICE IS "PEELING OFF." INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. PATIENT SWITCHED TO BACKUP INFUSION DEVICE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT 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 INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INSULIN| INSULIN INFUSION SET