BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3924515 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19481
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 19, 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 08/07/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE TEXT ON THE DISPLAY SCREEN WAS DIM/FADED AND DISCOLORED. UNRELATED TO THE DISPLAY ISSUE, THE BATTERY COMPARTMENT HAD MULTIPLE CRACKS, ONE AT OPENING OF BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL AND ONE BELOW THE FINGER PAD EXTENDING DOWN TO THE PRIMARY SEAL. A TEST BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL O-RING WAS SEATED AND CAP WAS FLUSH WITH THE PUMP CASE. THE YELLOW O-RING WAS VISIBLE THROUGH THE CRACK. THERE WAS NO ISSUE WITH A LOSS OF POWER AND NO EVIDENCE OF MOISTURE DAMAGE IN BATTERY COMPARTMENT. 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 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 DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. 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
    401317 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1