BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3970718 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-21946
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 09/15/2014 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON WITH THE RETURNED BATTERY CAP TO A DIM DISCOLORED DISPLAY. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN AND A BATTERY COMPARTMENT CRACK WAS OBSERVED BELOW THE GRIP. THERE WAS EVIDENCE OF MOISTURE CONTAMINATION INSIDE THE BATTERY COMPARTMENT AND ON THE UNDERSIDE OF THE BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO REBOOT, LOSS OF POWER OR CALL SERVICE ALARMS DUPLICATED. A LEAK TEST SHOWED A LEAK AT THE BATTERY COMPARTMENT CRACK. THE PUMP CASE WAS REMOVED FOR FURTHER INVESTIGATION, AND THERE WAS NO EVIDENCE OF ADDITIONAL MOISTURE CONTAMINATION INSIDE THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (DAMAGE WITH MOISTURE INGRESS) ISSUE. THE REPORTER STATED THAT THERE WAS NO AUDIBLE TONE, NO VIBRATION OR BACKLIGHT INDICATING NO POWER, AND THERE WAS UNSPECIFIED DAMAGE TO THE BATTERY COMPARTMENT AND MOISTURE IN THE PUMP. THE REPORTER DENIED DAMAGE TO THE BATTERY CAP AND STATED THAT THE BATTERY CAP HAD NEVER BEEN CHANGED. THE USER GUIDE RECOMMENDS CHANGING THE BATTERY CAP EVERY SIX MONTHS. 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
    446965 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR