BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3855069 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16204
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/29/2017 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED NO EVIDENCE OF A COMMUNICATION ALARM OR A CALL SERVICE ALARM. A TEST BATTERY CAP WAS USED FOR ALL TESTING. THE PUMP WAS RUN FOR 24 HOURS SUCCESSFULLY. NO REBOOTS, LOSS OF POWERS, OR CALL SERVICE ALARMS WERE DUPLICATED. THE PUMP CASE WAS REMOVED TO FIND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WERE FOUND INSIDE THE PUMP. NO COMMUNICATION ALARMS OR CALL SERVICE ALARMS WERE NOT DUPLICATED DURING THE INVESTIGATION. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (COMMUNICATION) ISSUE. IT WAS REPORTED THAT THE PUMP WAS EMITTING MULTIPLE CALL SERVICE ALARMS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334855 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR