BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3761311 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10686
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 05/20/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/12/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP BLACK BOX SHOWED MULTIPLE UNEXPLAINED POWER EVENTS. THE PUMP BATTERY COMPARTMENT AND CAP WERE OBSERVED TO BE INTACT. THE BATTERY CAP CONTACTS WERE MEASURED AND CONFIRMED TO BE WITHIN SPECIFICATIONS. THE BATTERY CAP WAS FOUND TO BE ABLE TO FULLY TIGHTEN TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES OR ALARMS. THE PUMP WAS OPENED AND THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR LOOSE COMPONENTS WITHIN THE PUMP. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER EVENT WHICH WAS RESOLVED BY REPLACING THE PUMP BATTERY. A REVIEW OF THE PUMP HISTORY FOUND NO INDICATION OF A BATTERY OR OTHER ALARM RELATED TO THE EVENT. 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
    240302 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR