BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® SPIRIT COMBO

    MDR report key: 3242367 · Received July 23, 2013

    Report

    Report Number
    2183996-2013-01348
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    July 20, 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 CANNOT BE VERIFIED DUE TO MISHANDLING OF THE PRODUCT. THE SOFT COMPONENT OF THE UP AND DOWN BUTTON IS DAMAGED DUE TO HANDLING WITH SHARP OBJECTS. THE BUTTONS SHOULD NOT BE ACTUATED BY USING HARD OR SHARP OBJECTS. DUE TO THE LEAKY SOFT COMPONENTS, LIQUID ENTERED THE PUMP AND CAUSED THE BUTTONS TO ALWAYS BE ACTIVE. THEREFORE, THE PATIENT WAS UNABLE TO PROGRAM A BOLUS.

    Description of Event or Problem · 1

    MOTHER REPORTED THE BUTTONS ON THE INFUSION DEVICE DO NOT FUNCTION. THE INFUSION DEVICE WENT INTO THE STOP MODE 3 TIMES AND THEN INTO THE RUN MODE WITHOUT PRESSING ANY BUTTONS. THE PATIENT TRIED TO BOLUS 9 UNITS OF INSULIN BUT WAS UNABLE TO. THE KEY-LOCK FEATURE WAS NOT ACTIVATED. SHE REMOVED THE BATTERY, BUT THIS DID NOT RESOLVE THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND 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
    342526 ACCU-CHEK ® SPIRIT COMBO INSULIN INFUSION PUMP LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1