BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3981121 · Received August 5, 2014

    Report

    Report Number
    2531779-2014-22439
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 28, 2014
    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 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 09/06/2014 WITH THE FOLLOWING FINDINGS: THERE WAS MOISTURE EVIDENT BEHIND THE DISPLAY LENS. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP SO A TEST BATTERY CAP WAS USED TO COMPLETE THE INVESTIGATION. THE TEST BATTERY CAP WAS ABLE TO FULLY TIGHTEN ONTO THE PUMP AND THERE WAS NO OBSERVED DAMAGE TO THE BATTERY COMPARTMENT. THE PUMP POWERED ON WITH AN AUDIBLE TONE, BUT THERE WAS NO VIBRATION AND A BLANK DISPLAY SCREEN. NO EVIDENCE OF MOISTURE INGRESS WAS FOUND INSIDE THE BATTERY COMPARTMENT. THE PUMP CASE WAS CRACKED IN THE UPPER RIGHT CORNER OF THE DISPLAY AREA. A LEAK TEST CONFIRMED THAT THERE WAS A PUMP CASE CRACK. EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND THROUGHOUT THE INTERNAL COMPONENTS OF THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. IT WAS ALLEGED THAT THE PUMP LOST POWER AND THERE WAS MOISTURE IN THE BATTERY COMPARTMENT. 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
    457454 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR