BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3040010 · Received April 8, 2013

    Report

    Report Number
    2531779-2013-03759
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/20/2013 WITH THE FOLLOWING FINDINGS: NO INSULIN DELIVERY DEFECT WAS FOUND. THE PUMP HISTORY SHOWS THE LAST BOLUS AND THE LAST BASAL WERE DELIVERED ON (B)(6) 2013. PUMP HISTORY SHOWS NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TDD; SHOWING THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. PUMP SUCCESSFULLY PASSED A 29HR FLOW ACCURACY TEST. NO ALARMS OCCURRED DURING TESTING. PUMP FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING ACCURATELY. UNRELATED TO THE COMPLAINT, OBSERVED A PINKISH CONTRAST ON THE DISPLAY SCREEN. 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) 2013, THE PATIENT CONTACTED ANIMAS AND ALLEGED THAT THE PUMP WAS NOT DELIVERING INSULIN ACCURATELY. WHEN HE MANUALLY COMPARED AMOUNT DISPENSED TO THE AMOUNT MEASURED IN A SYRINGE, HE BELIEVED THE PUMP WAS DELIVERING 2 UNITS LESS THAT IT WAS PROGRAMMED TO. PATIENT DID NOT ALLEGE ANY BLOOD GLUCOSE EXCURSIONS RELATED TO THIS ISSUE, AND WAS UNWILLING TO TROUBLESHOOT THE PUMP. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PUMP IS NOT DELIVERING INSULIN ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144203 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR