BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3895762 · Received June 25, 2014

    Report

    Report Number
    2531779-2014-18356
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Report Date
    June 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. REVIEW OF BLACK BOX DATA FOUND A PROCESSOR RELATED AND AN OCCLUSION CALL SERVICE ALARMS ON THE EVENT DATE, WITH NO POWER ON REBOOT EVENT IN BETWEEN. A POWER ON REBOOT RECORD WAS FOUND TWO DAYS AFTER THE EVENT DATE. THE BATTERY COMPARTMENT AND CAP WERE INTACT. THE PUMP POWERED UP AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR PUMP EXERCISE WERE EXECUTED WITHOUT INCIDENCES. THE REPORTED POWER ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED DURING THE INVESTIGATION.

    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 POWER (NO POWER) ISSUE. REPORTEDLY, THE PUMP HAD LOST POWER AND THERE WAS NO EVIDENCE OF MOISTURE CORROSION IN THE PUMP. IT WAS REPORTED THAT THE BATTERY COMPARTMENT OR CAP WERE UNDAMAGED AND THE CAP WAS ABLE TO SECURE PROPERLY ON TO THE PUMP. THE REPORTER STATED THAT THE ISSUE WAS NOT RESOLVED WITH A NEW BATTERY. 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
    371654 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR