BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6283475 · Received January 27, 2017

    Report

    Report Number
    2531779-2017-02343
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Report Date
    January 4, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/22/2017 WITH THE FOLLOWING FINDINGS:. THE BATTERY COMPARTMENT IS CRACKED ABOVE AND BELOW THE BUMPER PAD. THE PUMP POWERS UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN. CONSECUTIVE ¿CS054/CS052/CS012¿ ALARMS WERE OBSERVED IN THE DL HISTORY. UNABLE TO VERIFY STEPS (6-7,10-11). REMOVED PUMP COVER; NO INTERMITTENT CONDITION WAS FOUND TO THE PCB. UNITY TEST CODE DOWNLOAD TOOL APPLICATION V 1.0.0 WAS USED TO UPLOAD TEST CODE V 1.0.7 TO MASTER/SLAVE/PERIPHERAL PROCESSORS AS PER (6001112), U17 SLAVE PROCESSOR UPLOAD WAS UNSUCCESSFUL, U17 SLAVE PROCESSOR FAILURE IS CONCLUDED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP BATTERY COMPARTMENT WAS DAMAGED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67959 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1