BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1250024 · Received November 14, 2008

    Report

    Report Number
    2183996-2008-01732
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 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
    WV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2008 THE PATIENT REPORTED THE PISTON ROD ON HER INSULIN INFUSION DEVICE IS NOT RETRACTING DURING THE CARTRIDGE CHANGE PROCESS. SHE STATED THE PISTON ROD IS TURNING BUT DOES NOT RETRACT. SHE SAID THAT ABOUT 1 WEEK AGO 50 UNITS OF INSULIN WAS SPILLED INTO THE CARTRIDGE CHAMBER. THE PATIENT CONFIRMED SHE IS USING AA ALKALINE BATTERIES AND STATED SHE CHANGED THE BATTERY COVER 1 WEEK AGO. THE PATIENT CHANGED TO A NEW BATTERY AND TRIED TO RETRACT THE PISTON ROD WITHOUT SUCCESS. THE PATIENT STATED SHE SWITCHED TO INSULIN INJECTION THERAPY. NO BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE WERE REPORTED. THE PATIENT 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 63 YR INSULIN| INSULIN INFUSION SET