BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2070362 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01088
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT'S CAREGIVER REQUESTED ASSISTANCE WITH FILLING A NEW INSULIN CARTRIDGE AND COMPLETING THE CHANGE THE CARTRIDGE FUNCTION. ASSISTED CAREGIVER WITH FILLING A NEW INSULIN CARTRIDGE. CAREGIVER REPORTED, THE INFUSION DEVICE'S DISPLAY IS BLANK. HAD CAREGIVER INSERT A NEW BATTERY. INFUSION DEVICE STARTED UP AS NORMAL. ASSISTED CAREGIVER THROUGH THE CHANGE THE CARTRIDGE FUNCTION. HAD CAREGIVER GO INTO ALARM HISTORY. CAREGIVER STATED THERE WERE MULTIPLE E2 (BATTERY DEPLETED) ERROR MESSAGES THAT OCCURRED TODAY AND YESTERDAY. CAREGIVER REPORTED NO A2 (BATTERY LOW) ERROR MESSAGE WAS DISPLAYED. PT IS BLIND. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    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 53 YR INSULIN| INSULIN INFUSION SET