BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3952133 · Received July 23, 2014

    Report

    Report Number
    2531779-2014-21008
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Report Date
    July 10, 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 09/11/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE SCREEN WAS FULLY FUNCTIONAL AND WAS FULLY ILLUMINATED WITH NO SIGNS OF EXTRINSIC LINES VISIBLE ON THE DISPLAY. THE LINE THROUGH DISPLAY COMPLAINT COULD NOT BE DUPLICATED. UNRELATED TO THE DISPLAY SCREEN, THE BATTERY COMPARTMENT WAS CRACKED AT THE OPENING OF THE BATTERY CHAMBER EXTENDING DOWN TO THE PRIMARY SEAL. A TEST BATTERY CAP WAS ABLE TO FULLY TIGHTEN UNTIL THE O-RING WAS SEATED AND CAP WAS FLUSH WITH THE PUMP CASE. THERE WAS NO OBSERVED ISSUE WITH A LOSS OF POWER. THERE WAS NO EVIDENCE OF MOISTURE DAMAGE IN THE BATTERY COMPARTMENT.

    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 (LINE THROUGH DISPLAY) 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
    431485 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1