BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3791466 · Received May 5, 2014

    Report

    Report Number
    2531779-2014-12512
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/23/2014 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/19/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED NO EVIDENCE OF POWER REBOOTS WAS RECORDED. NO BATTERY CAP WAS RETURNED WITH THE PUMP. A TEST BATTERY CAP WAS USED TO COMPLETE TESTING. THE TEST BATTERY CAP WAS ABLE TO BE FULLY SECURED TO THE PUMP. DURING TESTING, THE PUMP POWERED ON AND THE DISPLAY WAS FOUND TO BE BLANK. A TEST DISPLAY WAS INSERTED AND FOUND TO FUNCTION PROPERLY. THE PUMP CASE WAS REMOVED AND NO INTERMITTENT CONDITION WAS FOUND TO THE POWER CIRCUIT. THE COMPLAINT OF THE PUMP LOSING POWER WAS NOT ABLE TO BE INVESTIGATED DUE TO THE UNRELATED BLANK DISPLAY ISSUE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP WAS INTERMITTENTLY LOSING POWER. 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
    266421 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR