BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4111092 · Received September 23, 2014

    Report

    Report Number
    2531779-2014-27164
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION OF THE PUMP FOUND SOME COSMETIC DAMAGES. USING THE RETURNED BATTERY CAP, THE PUMP POWERED UP WITH AUDITORY AND VIBRATORY FEATURES. MOISTURE WAS OBSERVED BEHIND THE DISPLAY SCREEN. A LEAK TEST SHOWED A LEAK ON THE DISPLAY LENS. PUMP CASING WAS OPENED AND MOISTURE WAS EVIDENT ON THE PRINTED CIRCUIT BOARD. UNRELATED TO THE MOISTURE INTRUSION ISSUE, THE DISPLAY SCREEN WAS DIM AND DISCOLORED. IN ADDITION, THE ¿UP¿ ARROW BUTTON RESPONDED INTERMITTENTLY AND REMOVAL OF KEYPAD COVER FOUND CONTAMINATION UNDER THE CONTRAST AND ¿UP¿ BUTTON CONTACTS.

    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 REPORTER CONTACTED ANIMAS, ALLEGING A CASING/CONDITION (MOISTURE INGRESS) ISSUE; 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
    592494 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1