BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4744631 · Received May 2, 2015

    Report

    Report Number
    2531779-2015-14804
    Event Type
    Malfunction
    Date Received
    May 2, 2015
    Report Date
    April 21, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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

    FOLLOW-UP #1: DATE OF SUBMISSION 06/26/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/010/2015 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE ALLEGED LOSS OF PRIME ISSUE WAS VERIFIED IN THE BLACK BOX BUT NOT DUPLICATED IN THE EVALUATION. REVIEW OF BLACK BOX DATA FOUND LOSS OF PRIME WARNINGS DUE TO NON-ZERO LOW FORCE. USING TEST BATTERY CAP AND TEST CARTRIDGE CAP, THE PUMP POWERED UP TO AND FUNCTIONED PROPERLY. A REWIND/LOAD/PRIME SEQUENCE AND A 24-HOUR BASAL EXERCISE WERE EXECUTED WITHOUT INCIDENCES. NORMAL AND AUDIO BOLUS WERE COMPLETED AND RECORDED CORRECTLY. THE FORCE SENOR CALIBRATION READING WAS WITHIN SPECIFICATIONS. PUMP CASING WAS OPENED AND NO DAMAGES WERE FOUND TO THE FORCE SENSOR CIRCUIT.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. REPORTEDLY, THE PUMP ALERTED FOR LOSS OF PRIME MULTIPLE TIMES AND THE ALERTS PERSISTED WITH CARTRIDGE AND INFUSION SET CHANGES. 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
    289734 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1