BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3253723 · Received July 30, 2013

    Report

    Report Number
    2183996-2013-01427
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 22, 2013
    Report Date
    September 4, 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 CANNOT BE VERIFIED DUE TO A MISHANDLING OF THE PRODUCT. THE SOFT COMPONENT OF THE UP AND DOWN BUTTON IS DAMAGED DUE TO HANDLING WITH SHARP OBJECTS. THE BUTTONS SHOULDN'T BE ACTUATED BY USING HARD OR SHARP OBJECTS. DUE TO THE LEAKY SOFT COMPONENTS, LIQUID ENTERED THE PUMP ELECTRONICS. THE RESULTING SHORT CIRCUIT DAMAGED THE PUMP ELECTRONICS, DISPLAY, BUTTONS (ALL BUTTONS ARE WITHOUT FUNCTION) AND LED TO THE FOLLOWING UNCLEARABLE E7 ERROR MESSAGE.

    Description of Event or Problem · 1

    MOTHER REPORTED THE INFUSION DEVICE DISPLAYED AN E7 ELECTRONIC ERROR AND THE BUTTONS WERE UNRESPONSIVE. SHE CHANGED THE BATTERY AND BATTERY COVER BUT WAS UNABLE TO CLEAR THE ERROR MESSAGE. SHE REMOVED THE BATTERY AND REINSERTED IT ON THE MORNING OF THE REPORT, AND THE DISPLAY WAS ILLEGIBLE AND THE INFUSION DEVICE PRODUCED AUDIBLE BEEPS. THE PATIENT SWITCHED TO MULTI-INJECTION THERAPY. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND THE PATIENT DID NOT REQUIRE TREATMENT TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355379 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1