BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3180053 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08617
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Report Date
    May 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 07/31/2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/10/2013 WITH THE FOLLOWING RESULTS: PUMP POWERS TO AN AUDIBLE TONE, NO VIBRATION AND BLANK SCREEN DUE TO INTERNAL MOISTURE CONTAMINATION. MOISTURE VISIBLE BEHIND DISPLAY LENS. PUMP CASE CRACKED IN UPPER RIGHT HAND CORNER OF THE DISPLAY AREA. LEAK TEST SHOWS LEAK AT CRACK IN PUMP CASE. BATTERY COMPARTMENT INTACT, NO CRACKS. NO EVIDENCE OF MOISTURE CONTAMINATION INSIDE BATTERY COMPARTMENT. BATTERY CAP IS UNABLE TO FULLY TIGHTEN DUE TO DAMAGED CAP THREADS. A TEST CAP WAS USED FOR ALL TESTING AND WAS ABLE TO FULLY TIGHTEN. A POWER LOSS WAS NOT OBSERVED. REMOVED PUMP CASE. EVIDENCE OF MOISTURE CONTAMINATION FOUND THROUGHOUT THE INSIDE OF THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER STATED THAT THE PUMP HAD LOST POWER AND WOULD NOT SHOW THE VERIFY SCREEN AFTER BEING EXPOSED TO WATER. THE REPORTER DENIED ANY DAMAGE TO THE BATTERY CAP OR 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
    279841 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR