BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 6445654 · Received March 30, 2017

    Report

    Report Number
    2531779-2017-06661
    Event Type
    Malfunction
    Date Received
    March 30, 2017
    Report Date
    March 11, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    OYC
    UDI-DI
    10840406100242
    PMA / PMN Number
    P130007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/05/2017 WITH THE FOLLOWING FINDINGS: BATTERY COMPARTMENT AND CAP ARE UNDAMAGED, CAP CONTACTS MEASUREMENTS ARE: HEIGHT (0.388, 0.388, 0.387, AND 0.389) INCH, WIDTH (0.584, 0.582) INCH, WITHIN SPEC.. THE PUMP POWERS UP WITH AUDITORY AND VIBRATION TO A BLANK SCREEN, UNABLE TO VERIFY STEPS (4, 6-7, 10-13, 21-22) AND TO ADEQUATELY INVESTIGATE REPORTED ¿INTERMITTENT POWER¿ COMPLAINT. PUMP'S COVER WAS REMOVED, U22 EEPROM 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. DURING INVESTIGATION, THE BATTERY COMPARTMENT AND CAP WERE UNDAMAGED. THE BATTERY CAP CONTACT MEASUREMENTS WERE WITHIN SPECIFICATIONS. THE PUMP POWERED UP WITH THE AUDITORY AND VIBRATORY ALARMS TO A BLANK DISPLAY. THE INTERMITTENT POWER COMPLAINT WAS UNABLE TO BE INVESTIGATED. THE PUMP COVER WAS REMOVED TO FIND THE EEPROM CRACKED. AN EEPROM FAILURE WAS DETERMINED TO BE THE CAUSE OF THE ISSUE.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE USER MAY BE UNAWARE THAT THE PUMP HAS LOST POWER, LEADING TO UNDER DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229396 ANIMAS VIBE INSULIN INFUSION PUMP OYC ANIMAS CORPORATION 10840406100242

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR