BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3201026 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09474
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 25, 2013
    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

    FOLLOW-UP #1: DATE OF SUBMISSION 10/23/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/11/2013 WITH THE FOLLOWING FINDINGS:THE PUMP POWERED ON TO THE VERIFY SCREEN WITH APPROPRIATELY AUDIBLE TONES AND VIBRATION. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ALARMS OR OTHER ISSUES DUPLICATED. A 10 UNIT NORMAL BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED AND WERE RECORDED ACCURATELY IN THE PUMP HISTORY. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DISCOLORED. THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE PUMP DISPLAY RETURNED TO NORMAL. 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 RELATED TO A LOSS OF PRIME ON THE PUMP. DURING TROUBLESHOOTING OF THE LOSS OF PRIME, ONE BOLUS ENTRY WAS NOTED TO BE MISSING IN THE PUMP BOLUS HISTORY. THE PATIENT INDICATED THAT A BOLUS WAS DELIVERED AT 6:31 PM ON (B)(6) 2013 AND ANOTHER WAS AT 6:51 PM BUT THERE WAS ONE BOLUS IN BETWEEN THAT WAS NOT LISTED IN THE BOLUS HISTORY. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP BOLUS HISTORY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303150 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR