BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3914015 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18928
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 - PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/07/2015 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS UNABLE TO BE CONFIRMED OR DUPLICATED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX FOUND NO RELATED ALARMS OR ISSUES; DATA RELEVANT TO THE COMPLAINT DATE WAS OVERWRITTEN DUE TO CONTINUED PUMP USE. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM; NO ABNORMAL NOISES WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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 THE PUMP EMITTED A SPITTING SOUND FOR 40-60 MINUTES AND THE PATIENT¿S BLOOD GLUCOSE DROPPED 108 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED. 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
    391718 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR