BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1933173 · Received December 14, 2010

    Report

    Report Number
    2183996-2010-02624
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE INFUSION DEVICE PISTON ROD HAS STUCK 2 TIMES DURING RETRACTION. CORRECT TYPE OF BATTERY IS USED IN INFUSION DEVICE, AND BATTERY TYPE IS PROGRAMMED CORRECTLY. THE CARTRIDGE PLUNGER WAS NOT STUCK ON THE PISTON ROD. PT COMPLETED CARTRIDGE CHANGE PROCEDURE DURING TROUBLESHOOTING CALL. THE PISTON ROD SOUNDED NORMAL DURING RETRACTION, AND THERE WERE NO GRINDING NOISES. THE PISTON ROD DID NOT BECOME STUCK. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO MOISTURE. THERE WAS NO APPARENT PHYSICAL DAMAGE. PT REQUESTED REPLACEMENT INFUSION DEVICE DUE TO CONCERN PISTON ROD MIGHT BECOME STUCK IN THE FUTURE. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR INSULIN INFUSION SET| INSULIN