BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3172438 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08276
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/09/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/16/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP WAS OBSERVED TO HAVE VISIBLE MOISTURE IN THE DISPLAY LENS. THE PUMP DOES NOT POWER ON AND HAD NO AUDIBLE OR VIBRATORY SOUNDS. THE DISPLAY SCREEN REMAINED BLANK AND DID NOT GO TO THE VERIFY SCREEN. THE PUMP¿S BLACK BOX HISTORY COULD NOT BE DOWNLOADED. DURING INVESTIGATION, A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND TO THE AUDIO BOLUS BUTTON. THE PUMP COVER WAS REMOVED AND MOISTURE WAS OBSERVED INSIDE THE PUMP. ADDITIONAL TESTS WERE NOT ABLE TO BE PERFORMED DUE TO MOISTURE INGRESS. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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 AND ALLEGED THAT TODAY AT BEACH, WHEN HE WENT INTO WATER FOR FEW SECONDS, PUMP STARTED VIBRATING. HE MANUALLY REMOVED BATTERY AND MANUALLY REINSERTED BATTERY TO STOP VIBRATION. HE STATED PUMP DID BOOT UP AND NOW PUMP JUST VIBRATES WITH NO DISPLAY, STATES THAT BATTERY LOOKS OXIDIZED, NO PHYSICAL DAMAGE TO PUMP, NO CRACKS, NO KEYPAD DAMAGE, NO WATER VISIBLE IN BATTERY COMPARTMENT. HE CAN SEE WATER AND FOG IN DISPLAY. HE REMOVED LENS FILM WHILE ON PHONE AND STILL SEES WATER IN DISPLAY. HE HAS NOT CHANGED BATTERY CAP AND STATES BATTERY CAP HAS WEAR AND TEAR FROM REMOVING AND SCREWING ON CAP WHERE COIN IS INSERTED, BUT NO DAMAGE TO THREADING OF PUMP BATTERY COMPARTMENT AND BATTERY CAP. HE HAS AN ALTERNATIVE INSULIN DELIVERY PLAN AND WILL DISCONTINUE PUMP USE. THERE IS NO ADVERSE EVENT RELATED TO THIS ISSUE. THIS COMPLAINT IS BEING REPORTED AS THE ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272822 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR