BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6462810 · Received April 5, 2017

    Report

    Report Number
    2531779-2017-07154
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Report Date
    March 16, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/14/2017 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT IS CRACKED BELOW THE GRIP PAD. RETURNED BATTERY CAP IS UNDAMAGED AND ABLE TO FIT SECURELY. THE PUMP POWERS UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN. REPORTED ¿BLANK SCREEN¿ COMPLAINT IS DUPLICATED. THE PUMP¿S COVER WAS REMOVED, U22 EEPROM COMPONENT WAS FOUND CRACKED. A 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE 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. INITIAL REPORTER: (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN) ISSUE. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE MAY RESULT IN AN INABILITY TO USE THE PRODUCT WHICH MAY LEAD TO LONG TERM CESSATION OF DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244315 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1