BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3233450 · Received July 18, 2013

    Report

    Report Number
    2183996-2013-01322
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 15, 2013
    Report Date
    September 3, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS, INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CAN BE VERIFIED. THE PUMP ONLY SHOWS THE WORD "VERSION" DURING STARTUP. NO ERROR OR WARNING WITH THIS WORDING EXISTS. E7910 ERRORS WERE FOUND IN THE HISTORY, AND THE PUMP TRIGGERS THE E7910 DURING STARTUP OF THE PUMP. THE EEPROM (MEMORY MODULE) IS DEFECTIVE AND THE PUMP CORRECTLY TRIGGERED THE E7910. THE BUTTONS MEET THE SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION DEVICE DISPLAYED AN UNKNOWN ERROR MESSAGE AND STARTED TO BEEP AND VIBRATE ON (B)(6) 2013. SHE THOUGHT THE DISPLAY READ "VERSION 2." SHE REMOVED AND REINSERTED THE BATTERY AND WAS UNABLE TO CLEAR THE ERROR MESSAGE BY PRESSING THE CHECK BUTTON. SHE BEGAN TO DELIVER INSULIN VIA PEN, AND THE ALLEGED INFUSION DEVICE WAS REQUESTED FOR EVALUATION. SHE 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
    335112 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1