BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3023424 · Received March 27, 2013

    Report

    Report Number
    2531779-2013-03136
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REBOOTS ARE OBSERVED IN THE BLACK BOX. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. A TEST CAP WAS USED FOR ALL INVESTIGATION STEPS. PUMP POWERS ON NORMAL WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 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.

    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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT AFTER A BATTERY CHANGE, THE PUMP KEPT GOING TO THE VERIFY SCREEN. THE PATIENT REPORTED CHANGING THE BATTERY THREE TIMES AND THE ISSUE WAS RECURRING. THE PATIENT CONFIRMED NO YELLOW O-RING VISIBLE AND CONFIRMED NO KNOWN TRAUMA TO THE PUMP. THERE WAS NO REPORTED ADVERSE EVENT RELATED TO THIS ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE INTERMITTENT POWER ISSUE WHICH WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126283 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR