BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK SPIRIT

    MDR report key: 1946000 · Received December 28, 2010

    Report

    Report Number
    2183996-2010-02675
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 17, 2010
    Report Date
    December 17, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED RECEIVING AN E2 (BATTERY DEPLETED) ALERT MESSAGE. PT STATED SHE DID NOT RECALL SEEING AN A2 (BATTERY LOW) ALERT DISPLAYED. HAD PT GO INTO ALARM HISTORY; VERIFIED THAT THE A2 (BATTERY LOW) ALERT WAS NEVER DISPLAYED. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT 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 EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN INFUSION SET| INSULIN