BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 3220997 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01264
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    July 7, 2013
    Report Date
    September 9, 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

    THE 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 SOFT COMPONENT OF THE UP BUTTON IS DAMAGED DUE TO HANDLING WITH SHARP OBJECTS. THE BUTTONS SHOULD NOT BE ACTUATED BY USING HARD OR SHARP OBJECTS. THIS SOURCE LED TO AN ALWAYS ACTIVATED UP BUTTON AND UNCLEARABLE E8 ERROR MESSAGES. DUE TO THE LEAKY SOFT COMPONENTS LIQUID ENTERED THE PUMP ELECTRONICS. THE RESULTING SHORT CIRCUIT DAMAGED THE PUMP ELECTRONICS AND LED TO THE E8 ERROR MESSAGE, AND A HIGH POWER CONSUMPTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT WAS SLEEPING AND WHEN HE WOKE UP HIS INFUSION DEVICE WAS TURNED OFF. THE PATIENT REPLACED THE BATTERY AND THEN THE DEVICE DISPLAYED E8 (POWER INTERRUPT). THE PATIENT STATED THAT THE MENU BUTTON WAS NO LONGER FUNCTIONING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319683 ACCU-CHEK SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS INC 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1