BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 7170770 · Received January 7, 2018

    Report

    Report Number
    2531779-2018-00426
    Event Type
    Malfunction
    Date Received
    January 7, 2018
    Report Date
    December 11, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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

    DATE OF SUBMISSION (B)(4) 2018 PMA/510 (K) #: K080639

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11-JAN-2018 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX AND ALARM HISTORY SHOWED A MANUALLY PROGRAMMED BOLUS OF 0.00U. DURING TESTING, THE PUMP SUCCESSFULLY COMPLETED THE REWIND, LOAD, AND PRIME STEPS WITHOUT ISSUE AND ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP SUCCESSFULLY COMPLETED THE 24 HOUR DURATION TEST ACCURATELY AND WITHOUT ISSUE, WHICH WAS ACCURATELY RECORDED IN THE PUMP HISTORY. A 10U MANUAL BOLUS AND A 10U AUDIO BOLUS WERE PERFORMED SUCCESSFULLY, BOTH OF WHICH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE KEYPAD BUTTONS WERE FOUND TO BE APPROPRIATELY RESPONSIVE. THE ORIGINAL COMPLAINT OF A HISTORY/SETTINGS ISSUE WAS UNABLE TO BE DUPLICATED. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE) ISSUE. IT WAS REPORTED THAT THE PUMP WAS DELIVERING BOLUS THAT WAS NOT PROGRAMMED. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE AN ISSUE WITH THE PUMP NOT PERFORMING AS INTENDED WITH REGARDS TO THE HISTORY OR THE SETTINGS MAY RESULT IN OVER OR UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14463 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR