BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181596 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08716
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 27, 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

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 08/23/2013. 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.DEVICE EVALUATION: ON EXAMINATION, THERE WAS VISIBLE MOISTURE BEHIND THE DISPLAY LENS. THE PUMP HAS A VISIBLE CRACK IN THE CASING AT THE RIGHT-HAND CORNER OF THE DISPLAY SCREEN. A LEAK TEST REVEALED LEAKAGE AT THE SIGHT OF THE CRACK. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED INTERNAL MOISTURE DAMAGE AFFECTING THE INTERNAL COMPONENTS, INCLUDING MISCELLANEOUS ELECTRICAL COMPONENTS. COMPLETE TESTING COULD NOT BE PERFORMED DUE TO THE MOISTURE DAMAGE TO THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (MOISTURE INGRESS) ISSUE. REPORTEDLY AFTER REMOVING THE BATTERY TO CLEAR AN ALARM, THE PUMP WOULD NOT POWER BACK ON. 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
    282858 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR