BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3953635 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21196
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED NO ACTIVITY RELATED TO THE COMPLAINT WAS RECORDED. DURING TESTING, THE PUMP POWERED ON TO A BLANK DISPLAY. THE DISPLAY SCREEN WAS FOUND TO BE CRACKED. A TEST DISPLAY WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. THE COMPLAINT THAT THE PUMP HAD NO POWER WAS NOT ABLE TO BE DUPLICATED DURING 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 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 (NO POWER) ISSUE. IT WAS REPORTED THAT THE PUMP HAD NO POWER. IT WAS NOTED THAT THE POWER ISSUE OCCURRED DURING OR IMMEDIATELY AFTER A BATTERY CHANGE. 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
    430119 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR