BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2884783 · Received December 3, 2012

    Report

    Report Number
    2183996-2012-01864
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    July 23, 2012
    Report Date
    April 18, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS RECEIVED FOR EVALUATION ON (B)(4) 2013. THE COMPLAINT CANNOT BE VERIFIED, AND THE PRODUCT MEETS THE SPECIFICATIONS REGARDING THE CUSTOMERS ALLEGATION. THE DELIVERY ACCURACY AND THE OCCLUSION LIMITS WERE TESTED WITHIN THE PUMP DRIVE TEST ON THE DIAGNOSTIC TEST SYSTEM AND BOTH MEET THE SPECIFICATIONS. ALL ALARM FUNCTIONS WERE TESTED SUCCESSFULLY AND NO MALFUNCTION COULD BE OBSERVED DURING THE TECHNICAL INVESTIGATION. THE BATTERY COVER PASSED THE OPTICAL INSPECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PT REPORTED THAT THE INFUSION DEVICE CHANGES FROM RUN TO STOP MODE W/O WARNING. THIS HAS BEEN OCCURRING FOR 3.5-4 MONTHS. SHE STATED THE ISSUE LAST OCCURRED ABOUT A MONTH AGO. THE PT REVIEWED THE ALARM HISTORY AND AN E4 (OCCLUSION) ERROR WAS LISTED ON (B)(6) 2012. AT THAT TIME THE PT GAVE THE INFUSION DEVICE TO A NURSE WHO ASSISTS HER AND THE NURSE WAS ABLE TO CLEAR ERROR. SHE STATED THAT SHE IS CERTAIN THE INFUSION DEVICE DID NOT DISPLAY AN ALERT OR ERROR MESSAGE WHEN IT WENT INTO STOP MODE. THE PT DID NOT REQUIRE TREATMENT WHEN IT WENT INTO STOP MODE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE WS REPLACED. THE INFUSION DEVICE, BATTERY, AND BATTERY COVER WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN