BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3771891 · Received April 24, 2014

    Report

    Report Number
    2531779-2014-11342
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND AT A TEAR IN THE KEYPAD COVER. THE PUMP CASE WAS REMOVED AND MOISTURE DAMAGE WAS OBSERVED INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS BLANK AND THAT THE PUMP¿S VIBRATORY ALARMS WERE NOT FUNCTIONING.

    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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE. THE REPORTER ALLEGED THAT THERE WAS MOISTURE BEHIND THE DISPLAY. 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
    248716 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR