BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3181770 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08723
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 25, 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 DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/26/2013 WITH THE FOLLOWING RESULTS: MOISTURE CONTAMINATION OBSERVED BEHIND DISPLAY LENS. PUMP POWERS TO VERIFY SCREEN, AUDIBLE TONE, NO VIBRATION. UPON POWER UP KEYPAD AUTO-SCROLLS FROM "HOUR FUNCTION" TO "CONFIRM" DUE TO INTERNAL MOISTURE DAMAGE. PUMP IS THEN UNRESPONSIVE. . BATTERY COMPARTMENT CRACK OBSERVED IN THE THREAD AREA. NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT . BATTERY CAP UNABLE TO FULLY TIGHTEN DUE TO BATTERY COMPARTMENT CRACK. A TEST CAP WAS ALSO UNABLE TO FULLY TIGHTEN. PUMP CASE CRACK OBSERVED. LEAK TEST SHOWS LEAK AT CRACK IN PUMP CASE. REMOVED PUMP CASE. EVIDENCE OF MOISTURE CONTAMINATION FOUND THROUGHOUT THE INSIDE OF THE PUMP AND ON KEYPAD FLEX CABLE AND CONNECTOR. 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 NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S MOM REPORTS PATIENT SWIMMING WITH PUMP ON TODAY AND NOW THE PUMP WON¿T TURN ON: THERE IS WATER BEHIND THE DISPLAY AND THE DISPLAY IS BLANK AT THIS TIME. THERE IS NO DAMAGE OR TRAUMA TO THE PUMP. 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
    282190 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR