BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3070129 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04716
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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: A REVIEW OF THE PUMP HISTORY INDICATED NO BOLUS RECORDED. THE REWIND, PRIME AND LOAD STEPS WERE PERFORMED ON THE PUMP WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO ALARMS NOTED. DURING TESTING, 2 BOLUSES WERE SUCCESSFULLY PERFORMED ON THE PUMP AND BOTH ACCURATELY RECORDED IN PUMP HISTORY. THE PUMP WAS OPENED AND NO DEFECTS WERE FOUND. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAL AND ALLEGED THAT THE PUMP HAD AN 3.00 UNIT BOLUS IN THE HISTORY FOR (B)(6) 2013, WHICH THE PATIENT HAD NOT PROGRAMMED. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED THE HISTORY AND CONFIRMED THE BOLUS AT 9:03 A.M. ON (B)(6) 2013. ALL OTHER BOLUSES ACCOUNTED FOR. THERE IS NO ADVERSE EVENT REPORTED IN RELATION TO THIS ISSUE. THIS COMPLAINT IS BEING REPORTED DUE TO THE ALLEGATION THAT THE PUMP DELIVERED A BOLUS THAT HAD NOT BEEN PROGRAMMED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172808 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR