BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1041362 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00682
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 1, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT FOR AT LEAST ONE MONTH, THE PISTON ROD OF HER INFUSION DEVICE WILL NOT EXTEND PAST 174 UNITS. SHE STATED THAT WHEN THIS OCCURS SHE REMOVES THE INSULIN CARTRIDGE AND RESETS THE INFUSION DEVICE TO 315 UNITS AND THEN USES THE ARROW BUTTONS OF THE INFUSION DEVICE TO PRIME THE PISTON ROD PAST 174 UNITS. SHE STATED THAT THE PISTON ROD MAKES A LOUD NOISE AND "WAS HESITATING LIKE IT WILL NOT GO ANY FURTHER." SHE REPORTED THAT ONE WEEK AGO 1/4TH OF A CARTRIDGE OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT WHEN THE PLUNGER OF THE CARTRIDGE BECAME STUCK TO THE PISTON ROD. SHE WAS ABLE TO REMOVE THE PLUNGER FROM THE PISTON ROD. THE PATIENT SWITCHED TO HER BACKUP INFUSION DEVICE. FURTHER ATTEMPTS TO FOLLOW UP WITH THE PATIENT WERE UNSUCCESSFUL. 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 INSULIN| INSULIN INFUSION SET