BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1202503 · Received October 8, 2008

    Report

    Report Number
    2183996-2008-01553
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 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
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT HIS INFUSION DEVICE STOPPED FUNCTIONING AND IT DID NOT GIVE AN ALERT OR ERROR MESSAGE. HE STATED THAT HE HIT THE INFUSION DEVICE WITH HIS GOLF CLUB AND THEN NOTICED THAT THE DISPLAY HAD GONE BLANK. HE INSERTED A NEW BATTERY, BUT THE DISPLAY REMAINED BLANK. THE BATTERY IN USE AT THE TIME OF THE INCIDENT, HAD BEEN IN PLACE FOR 2 DAYS. THE INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO EXTREME TEMPERATURES OR ELECTROMAGNETIC FIELDS. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 56 YR INSULIN| INSULIN INFUSION SET