BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3871238 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16904
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/17/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED SEVERAL REBOOT EVENTS ON (B)(4) 2014. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED AT THE THREADS; THE BATTERY CAP WAS UNDAMAGED AND WAS ABLE TO SECURE TO THE PUMP AND MAINTAIN ELECTRICAL CONNECTION. THE BATTERY CAP CONTACTS WERE FOUND TO BE WITHIN REQUIRED SPECIFICATIONS. THE BATTERY CAP WAS SECURED AND THEN UNFASTENED A HALF TURN WITH NO REBOOTS OBSERVED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. NO POWER INTERRUPTIONS OCCURRED DURING TESTING; THE PUMP PERFORMED WITHIN SPECIFICATIONS. THE PUMP CASING WAS REMOVED AND NO INTERMITTENT CONDITION WAS FOUND TO THE POWER CIRCUIT. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED.

    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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) 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
    351100 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR