BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1821280 · Received August 26, 2010

    Report

    Report Number
    2183996-2010-01732
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED THE PISTON ROD WAS STUCK DURING RETRACTION AND THE BASE PLATE OF THE PISTON ROD BROKE OFF. PT WAS COMPLETING CARTRIDGE CHANGE AND ATTEMPTED TO INSERT INSULIN CARTRIDGE. THE INSULIN CARTRIDGE WOULD NOT GO IN CORRECTLY; PT REMOVED THE INSULIN CARTRIDGE AND THE BASE PLATE OF THE PISTON ROD CAME OUT. PT THEN TRIED TO REWIND THE PISTON ROD. THE INFUSION DEVICE MOTOR WAS RUNNING BUT THE PISTON ROD WAS NOT MOVING. PT WAS USING CORRECT TYPE OF BATTERY THAT WAS INSERTED 3 DAYS PRIOR. INFUSION DEVICE WAS NOT DROPPED OR EXPOSED TO WATER OR INSULIN INGRESS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE 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 48 YR INFUSION SET| INSULIN