BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4240314 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-31992
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/10/2014 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE ALLEGED MOISTURE INGRESS ISSUE WAS VERIFIED. THE BATTERY COMPARTMENT WAS FOUND TO HAVE CRACKED ALONG THE LEFT SIDE OF THE GRIP PAD. A LEAK TEST SHOWED LEAKS AT THE BATTERY COMPARTMENT AND THE DISPLAY LENS. MOISTURE INTRUSION WAS EVIDENT INSIDE THE PUMP. THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. UNRELATED TO THE CASING ISSUE, A PINKISH CONTRAST WAS OBSERVED WITH THE DISPLAY SCREEN. THE KEYPAD BUTTONS RESPONDED INTERMITTENTLY. REMOVAL OF THE COVER FOUND CONTAMINATION UNDER ALL THE BUTTON CONTACTS. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING THAT MOISTURE WAS EVIDENT BEHIND THE DISPLAY. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED UNRESOLVED. 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
    721882 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1