BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1001323 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00150
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 4, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT THE PISTON ROD OF HER INFUSION DEVICE WILL NOT COMPLETELY RETRACT DURING A CARTRIDGE CHANGE. SHE ALSO STATED THAT THE INFUSION DEVICE MAKES AN AUDIBLE NOISE AND THERE IS "GREEN CRYSTALLIZATION" NEAR THE PISTON ROD. SHE STATED THAT SHE HAS EXPERIENCE THIS ISSUE FOR "A WHILE" BUT SHE HAS BEEN ABLE TO "REBOOT" THE INFUSION DEVICE BY REMOVING AND REINSERTING THE BATTERY. TO TROUBLESHOOT, THE PT WAS INSTRUCTED TO RETRACT THE PISTON ROD. SHE STATED THAT SHE COULD HEAR "CLICKING" BUT DID NOT SEE THE PISTON ROD RETRACT AND 315 DID NOT APPEAR ON THE DISPLAY OF THE INFUSION DEVICE. SHE THEN RECEIVED AN E10 (CARTRIDGE ERROR). THE PT STATED THAT SHE DOES NOT SHOWER OR SWIM WITH THE INFUSION DEVICE, BUT SHE WAS CERTAIN THAT MOISTURE HAD ENTERED THE CARTRIDGE COMPARTMENT (DETAILS NOT PROVIDED). NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD 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 INSULIN INFUSION SET| INSULIN