BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1811125 · Received August 13, 2010

    Report

    Report Number
    2183996-2010-01612
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 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
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PT REPORTED INFUSION DEVICE DISPLAYED CARTRIDGE ERROR (E10) WHEN ATTEMPTING TO RETRACT PISTON ROD. PT RECEIVED MECHANICAL ERROR (E6) EARLIER IN THE DAY, WHICH WAS CLEARED BY FOLLOWING TROUBLESHOOTING STEPS. PISTON ROD MADE ABNORMAL NOISE WHEN IT WAS RETRACTING. PISTON ROD WAS NOT GRINDING OR SPINNING BUT SOUNDED LIKE "IT WAS WORKING VERY HARD." PISTON ROD WOULD START AND STOP DURING RETRACTION. PT WAS USING CORRECT TYPE OF BATTERY. PT INSERTED TWO DIFFERENT BATTERIES, BUT THE INFUSION DEVICE WOULD NOT POWER ON. PT THEN INSERTED A BATTERY PREVIOUSLY USED, AND THE INFUSION DEVICE POWERED ON BUT DISPLAYED LOW BATTERY (A2) ALERT. PT INSERTED ANOTHER BATTERY, AND THE INFUSION DEVICE POWERED ON CORRECTLY. PT RETRACTED PISTON ROD. PISTON ROD CONTINUED TO RUN ROUGH AND STOPPED AND STARTED BEFORE PISTON ROD WAS FULLY RETRACTED. NO ALERTS OR ERRORS WERE RECEIVED DURING THIS RETRACTION. PT DOES NOT NOTICE THIS CONCERN WHEN PISTON ROD IS EXTENDING. INFUSION DEVICE HAS NOT BEEN EXPOSED TO INSULIN INGRESS. INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE 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 INSULIN| INFUSION SET