BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2971702 · Received January 30, 2013

    Report

    Report Number
    2183996-2013-00098
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 20, 2013
    Report Date
    April 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    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. DUE TO THE DAMAGED SOFT COMPONENTS, LIQUID ENTERED THE PUMP AND DAMAGED THE ELECTRONICS. THIS LED TO E8 POWER INTERRUPT ERROR MESSAGES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PT REPORTED SHE NOTICED THE INFUSION DEVICE WAS "DEAD" ON (B)(6) 2013 AT 10:00 PM. SHE REMOVED AND REINSERTED THE BATTERY, AND THE INFUSION DEVICE DISPLAYED AN E8 POWER INTERRUPT ERROR AND THEN SHUT-DOWN. SHE INSERTED A NEW BATTERY AND BATTERY COVER, AND THE INFUSION DEVICE DISPLAYED ANOTHER E8 POWER INTERRUPT ERROR AND SHUT-DOWN AGAIN. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND SHE DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WAS REQUESTED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41995 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS, INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES