BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3210958 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09765
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/13/2013 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT AND CAP WERE FOUND TO BE INTACT WITH NO PHYSICAL DAMAGE NOTED. THE PUMP POWERED ON NORMALLY AND THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT OVERHEATING OR ALARMS OCCURRING. THE PUMP ELECTRICAL CURRENT DRAWS WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. A LEAK TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE LEAKING FROM A CRACK IN THE TOP CORNER OF THE DISPLAY LENS. THE PUMP COVER WAS REMOVED AND MOISTURE DAMAGE WAS FOUND INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP ¿ MOISTURE INGRESS) ISSUE; CONDENSATION IN THE DISPLAY. THE PUMP WAS EXPOSED TO WATER THE PRIOR DAY. 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
    310871 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR