BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3954745 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21234
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 16, 2014
    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 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).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 08/11/2014 WITH THE FOLLOWING RESULTS: BLACK BOX SHOWS ¿LOSS OF PRIME¿ DUE TO LOW NON-ZERO FORCE . NO ¿LOSS OF PRIME¿ WAS DUPLICATED DURING THE INVESTIGATION, FORCE SENSOR CALIBRATION READING IS BELOW SPECIFICATION: FORCE SENSOR RESISTANCE IS WITHIN SPECIFICATION. NO CONTAMINATION OR INTERMITTENT CONDITION WAS FOUND TO THE FORCE SENSOR PLATE AND FLEX.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 SUBMITTED 7/24/2014. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) 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
    433598 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1