BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4191382 · Received October 21, 2014

    Report

    Report Number
    2531779-2014-29871
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    October 8, 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 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/25/2014 WITH THE FOLLOWING FINDINGS: THE PUMP'S BLACK BOX SHOWED FOUR CALL SERVICE 054 ALARMS ON THE REPORTED FAILURE DATE (B)(6) 2014; THE ALARMS RECORDED RIGHT AFTER REPLACE BATTERY ALARMS. THERE WAS NO PUMP REBOOT OBSERVED BETWEEN THESE TWO ALARMS. THE PUMP POWERED UP NORMALLY. AN EZPRIME SEQUENCE AND 24HR DURATION TEST WERE COMPLETED WITH THE RETURNED BATTERY AND RETURNED CARTRIDGE CAP. NO CALL SERVICE ALARMS WERE DUPLICATED DURING TESTING. THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OBSERVED. THERE WAS NO DAMAGE TO THE TRANSCEIVER WIRE OR PCB FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THERE WERE MULTIPLE CALL SERVICE 054 ALARMS FROM THE PUMP. 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
    669398 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR