BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3252118 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12013
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/25/2013 WITH THE FOLLOWING FINDINGS:ANY INFORMATION FROM THE DATE OF THE EVENT WAS NOT VIEWABLE IN THE PUMP¿S HISTORY DUE TO CONTINUED USE OF THE PUMP. THE AVAILABLE HISTORY SHOWED NO EVIDENCE OF REBOOTS. A VISUAL INSPECTION OF THE PUMP SHOWED THAT THE BATTERY COMPARTMENT WAS INTACT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN ON BUT A POWER LOSS WAS OBSERVED WHEN THE CAP WAS LOOSED BY HALF A TURN. THE BATTERY CAP CONTACT HEIGHT AND WIDTH WERE FOUND TO BE OUT OF SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS. THE PUMP COVER WAS REMOVED AND NO DAMAGE OR MOISTURE CORROSION WAS FOUND TO THE INTERNAL COMPONENTS. 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 A POWER (NO POWER) ISSUE. THE REPORTER STATED THAT THE PUMP HAD POWERED OFF WITHOUT USER INTERVENTION AT RANDOM. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353922 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR