BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2971684 · Received January 30, 2013

    Report

    Report Number
    2183996-2013-00105
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED DUE TO CARELESS HANDLING OF THE PRODUCT. ERROR E1 WAS FOUND IN THE HISTORY LIST. THE SOFT COMPONENTS OF THE HOUSING ARE WORN DOWN HEAVILY AND RESTRICTED HANDLING OF THE PUMP IS A POSSIBLE IMPLICATION. THEREFORE, MOISTURE ENTERED THE INSULIN PUMP AND DESTROYED THE FUNCTIONALITY OF THE BUTTONS AND THE PUMP ELECTRONICS. THE UP BUTTON IS PERMANENTLY ACTIVE DUE TO AN EXTERNAL MECHANICAL DAMAGE. THE CHECK BUTTON PASSED THE OPTICAL AND FUNCTIONAL INVESTIGATION SUCCESSFULLY AND MEETS THE SPECIFICATION. THE MENTIONED E1 ERROR IS NOT A MALFUNCTION OF THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PATIENT REPORTED THE INFUSION DEVICE DISPLAYED AN E1 CARTRIDGE EMPTY ERROR, AND HE WAS UNABLE TO CLEAR THE ERROR MESSAGE BY PRESSING THE CHECK BUTTON. HE INSERTED 2 NEW ALKALINE BATTERIES AND EACH TIME, THE INFUSION DEVICE COMPLETED THE SELF-CHECK AND IMMEDIATELY DISPLAYED THE E1 ERROR. THE BUTTONS ON THE INFUSION DEVICE WERE UNRESPONSIVE, AND THE KEY-LOCK FEATURE WAS NOT ACTIVATED. HE SWITCHED TO HIS BACKUP INFUSION DEVICE. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE 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
    41747 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 061 YR INSULIN| INSULIN INFUSION PUMP| RELATED ACCESSORIES