BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2022201 · Received March 11, 2011

    Report

    Report Number
    2183996-2011-00515
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    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
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ALL OF THE BUTTONS ON HIS INFUSION DEVICE ARE UNRESPONSIVE. PT STATED, HE RECEIVED AN E8 (POWER INTERRUPT) WHILE ATTEMPTING TO GET IT TO WORK. PT STATED, HE REMOVED AND REINSERTED THE BATTERY WHILE THE BUTTONS WERE NOT RESPONDING AND THAT IS WHEN THE E8 OCCURRED. PT REPORTED, HE HAS NOT BEEN ABLE TO PLACE THE INFUSION DEVICE IN STOP MODE BEFORE REMOVING THE BATTERY DUE TO THE BUTTONS BEING UNRESPONSIVE. PT STATED, HE CHANGED THE BATTERY AND AGAIN RECEIVED AN E8; BUTTONS WERE STILL UNRESPONSIVE. PT REPORTED THE BUTTONS DO DEPRESS, BUT THERE IS NO AUDIBLE SOUND. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVAL.

    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 19 YR INSULIN INFUSION SET| INSULIN