BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093834 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26455
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS UNABLE TO BE RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/16/2015. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/02/2015 WITH THE FOLLOWING FINDINGS: 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. ON INVESTIGATION, THE ALLEGED INTERMITTENT POWER ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED IN THE EVALUATION. REVIEW OF BLACK BOX DATA FOUND UNEXPLAINED POWER ON RESET EVENTS. RELATED TO THE COMPLAINT, MOISTURE CORROSION WAS EVIDENT INSIDE THE BATTERY COMPARTMENT WITH NO DAMAGES TO THE COMPARTMENT FOUND. THE BATTERY CAP CONTACT MEASUREMENTS WERE WITHIN SPECIFICATIONS AND IT WAS ABLE TO FULLY TIGHTEN ON TO THE PUMP. THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR BASAL EXERCISE WERE EXECUTED WITHOUT INCIDENCES. A LEAK TEST SHOWED A LEAK ON THE DISPLAY LENS. PUMP CASING WAS OPENED AND THERE WAS NO ADDITIONAL EVIDENCE OF MOISTURE INTRUSION INSIDE THE PUMP. NO DAMAGES TO THE POWER CIRCUIT WERE OBSERVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS ALLEGING AN INTERMITTENT POWER ISSUE. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO INDICATION THAT THE PRODUCT ISSUE 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
    571368 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR