BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243174 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01682
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 25, 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 PATIENT'S FATHER REPORTED THAT THE DISPLAY OF THE PATIENT'S BACKUP INFUSION DEVICE IS ONLY PARTIALLY VISIBLE. THE PATIENT REPORTED THAT HE NOTICED THE PARTIAL DISPLAY THE PREVIOUS DAY, WHEN HE REMOVED THE INFUSION DEVICE FROM HIS POCKET. HE STATED THAT ONLY PART OF THE TIME AND DATE IS VISIBLE, AND THE DISPLAY SHOULD READ "1.4 U/H" BUT ONLY ".4 U/H" IS VISIBLE. HE STATED THAT THE INFUSION DEVICE HAD NOT BEEN EXPOSED TO WATER, BUT HE HAS DROPPED IT AND HE MAY HAVE FALLEN ON IT. 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 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 24 YR INSULIN INFUSION SET| INSULIN