BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3180688 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08672
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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).

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 08/22/2013, 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. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA REVEALED NO EVIDENCE OF ¿LOAD STEP MALFUNCTION¿. ON TESTING, THE PUMP POWERED ON NORMALLY. AN EZ-PRIME FUNCTION WAS EXECUTED AND WAS PERFORMED WITHOUT ISSUE. THE FORCE SENSOR WAS NOTED TO BE WITHIN SPECIFICATIONS. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT OF A LOAD STEP MALFUNCTION. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED A DEFECTIVE FORCE SENSOR ASSEMBLY CONNECTOR WIRE.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2013 AND REPORTED A PRIME ISSUE WITH THE LOAD STEP AND/OR NOT RECOGNIZING THE CARTRIDGE. 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
    280589 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1