BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4132954 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28032
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 17, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/21/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX SHOWED ONE POWER EVEN OCCURRING ON (B)(6) 2014; THE PUMP BATTERY VOLTAGE RECORDED AT THE TIME WAS ABOVE THE THRESHOLD FOR A BATTERY ALARM. DURING TESTING, THE PUMP BATTERY COMPARTMENT WAS NOTED TO BE CRACKED FROM THE CASE SEAL TO THE BUMPER PAD. THE PUMP BATTERY CAP THREADS WERE NOTED TO BE STRIPPED AND THE BATTERY CAP WAS UNABLE TO SECURE AND MAINTAIN ELECTRICAL CONNECTION. A TEST BATTERY CAP WAS INSERTED INTO THE PUMP AND THE PUMP POWERED ON NORMALLY AND NO FURTHER POWER INTERRUPTIONS OCCURRED DURING TESTING. THE PUMP COVER WAS REMOVED AND NO INTERMITTENT CONDITIONS WERE OBSERVED INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS OBSERVED TO BE DIM AND DISCOLORED.

    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 THAT THE PUMP HAD AN ISSUE WITH INTERMITTENT POWER. THE REPORTER CONFIRMED THAT THERE WAS NO MOISTURE OF CORROSION IN THE PUMP AND CONFIRMED THAT THE BATTERY CAP WAS ABLE TO BE SECURED TO THE PUMP APPROPRIATELY. 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
    612367 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR