BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2874314 · Received December 14, 2012

    Report

    Report Number
    2531779-2012-14594
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO EVIDENCE OF A 'LOAD STEP MALFUNCTION' OR 'LOSS OF PRIME' WARNING. THE PUMP WAS FOUND TO BOOT UP NORMALLY WITH NO ISSUES. THE 'EZ-PRIME'/PRIME STEPS WERE SUCCESSFULLY PERFORMED ON HE PUMP. THE FORCE SENSOR WAS FOUND TO BE WITHIN CALIBRATION. NO ISSUES WERE FOUND WITH THE DISPLAY, FORCE SENSOR FLEX PINS OR WITH THE FORCE SENSOR CIRCUIT.

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THE PUMP EXPERIENCED A LOAD STEP MALFUNCTION. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PUMP REPORTEDLY HAD A LOAD STEP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1