BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3171862 · Received June 17, 2013

    Report

    Report Number
    2531779-2013-08271
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/14/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/17/2013 WITH THE FOLLOWING FINDINGS: THERE WAS VISIBLE MOISTURE AND CORROSION IN DISPLAY. UNABLE TO DOWN LOAD BLACK BOX AND HISTORY DUE TO IR PORT AND SURROUNDING COMPONENTS CORRODED. THE PUMP WAS POWERED UP AND RECEIVED BOTH THE AUDIO AND VIBRATOR ALARMS. THE DISPLAY WAS UNREADABLE WITH JUST COLORED DOTS AND LINES. A CRACK IN CASE WAS ON THE UPPER RIGHT SIDE BETWEEN THE LENS AND CASE SEAL. OPENED PUMP AND REMOVED FROM CASE. THE ENTIRE PUMP WAS CORRODED AND MOISTURE ON ALL SURFACES. THERE WAS MOISTURE IN PUMP AND A LEAK DUE TO CRACKED PUMP CASE. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED.

    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 DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE REPORTER NOTED MOISTURE BEHIND THE DISPLAY SCREEN. 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
    272819 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR