BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3984492 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22588
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 26, 2014
    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

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 10/02/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/22/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BOOTS TO THE VERIFY SCREEN WITH AUDIBLE AND VIBRATORY FEATURES. THE PUMP WAS EXERCISED FOR 24HRS WITH A 1.0U/HR BASAL PROGRAM; NO EAW¿S OCCURRED DURING THIS TIME. A NORMAL 10U BOLUS AND A 10U AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE PUMP HISTORY FOUND TO BE RECORDING PROPERLY. INVESTIGATORS WERE UNABLE TO DUPLICATE THE COMPLAINT. THE BATTERY COMPARTMENT IS CRACKED BELOW BUMPER PAD. RETURNED BATTERY CAP IS ABLE TO FULLY ATTACH TO THE PUMP AND WAS USED TO COMPLETE ALL TESTING. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY SETTINGS ISSUE. THE REPORTER STATED THAT SOMETIMES THE BOLUSES WERE NOT SHOWING UP IN THE MENU HISTORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459769 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR