BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1071781 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-00997
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    April 28, 2008
    Report Date
    June 28, 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
    WY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HER INSULIN INFUSION DEVICE IS "NOISY" AND SEEMS TO VIBRATE LOUDER AND HARDER THAN IT USED TO. SHE STATED THAT IT IS SO LOUD SHE TRIES TO COVER THE SOUND UP WHEN SHE BOLUSES IN PUBLIC. SHE STATED THE DEVICE HAS NOT BEEN DROPPED OR EXPOSED TO MOISTURE AND SHE HAS CHANGED THE BATTERY SEVERAL TIMES SINCE IT STARTED DOING THIS OVER TWO MONTHS AGO. THE PT STATED SHE WILL SWITCH TO HER PRIOR INFUSION DEVICE. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE 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 INSULIN| INSULIN INFUSION SET