BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6053598 · Received October 25, 2016

    Report

    Report Number
    2531779-2016-29592
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 2, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/07/2016 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE BATTERY COMPARTMENT/CAP ARE UNDAMAGED AND ABLE TO FIT SECURELY. THE PUMP POWERS UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN, UNABLE TO VERIFY STEPS AND TO ADEQUATELY INVESTIGATE REPORTED ¿POWER¿ COMPLAINT. THE PUMP¿S COVER WAS REMOVED, U22 EEPROM COMPONENT WAS FOUND CRACKED. UNITY TEST CODE DOWNLOADER TOOL APPLICATION V 1.0.0 WAS USED TO UPLOAD TEST CODE V 1.0.7 TO MASTER/SLAVE/PERIPH PROCESSORS AS PER (6001112). THE UPLOAD WAS SUCCESSFUL, THE PUMP POWERS UP AND DISPLAY JUST ¿MSP¿ INSTEAD OF ¿MSP2¿. (2) IS THE EEPROM COMMUNICATING PROPERLY HENCE THE DIAGNOSIS THAT THE FAILURE IS IN THIS AREA SINCE IT IS MISSING FROM THE DISPLAY. EEPROM FAILURE IS CONCLUDED. 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) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) 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
    704210 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR