BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3012337 · Received March 20, 2013

    Report

    Report Number
    2531779-2013-02837
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS DOWNLOADED USING (B)(4). THERE WERE NO MISSING BOLUSES OBSERVED. THE LOGBOOK APPEARS TO BE INACCURATE DUE TO A TIME AND DATE RESET. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THERE WERE NO HYPERSENSITIVE KEYS OBSERVED ON KEYPAD. THE COMPLAINT OF BOLUSES NOT RECORDING ACCURATELY IN THE PUMP HISTORY WAS NOT DUPLICATED DURING THE INVESTIGATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING THAT A REVIEW OF THE PUMP DOWNLOAD SHOWED MISSING BOLUSES IN THE PUMP HISTORY. TROUBLESHOOTING COULD NOT BE COMPLETED AT THE TIME OF INITIAL CONTACT. CUSTOMER TECHNICAL SUPPORT HAS ATTEMPTED TO FOLLOW UP WITH THE REPORTER TO COMPLETE TROUBLESHOOTING, WITHOUT SUCCESS. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115240 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR