BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1021842 · Received March 28, 2008

    Report

    Report Number
    2183996-2008-00393
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT SHE RECEIVED AN E2 (BATTERY DEPLETED) ERROR ON HER INFUSION DEVICE WHILE AT WORK. SHE STATED THAT SHE DID NOT RECEIVE THE PRIOR A2 ALERT WARNING HER THAT THE BATTERY WAS LOW. NO A2 ALARM WAS FOUND IN THE ALARM HISTORY. SHE STATED THAT THE BATTERY HAD BEEN IN USE FOR AT LEAST 7-8 WEEKS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN