BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3944552 · Received July 18, 2014

    Report

    Report Number
    2531779-2014-20688
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/08/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWED NO EVIDENCE OF SHORT BATTERY LIFE AND EVIDENCE OF MULTIPLE CALL SERVICE ALARMS. MOISTURE CORROSION WAS OBSERVED ON THE DISPLAY SCREEN INSIDE THE PUMP. THE PUMP POWERED ON WITH AN UNRESPONSIVE KEYPAD WHICH PROHIBITED FURTHER TESTING PAST THE VERIFY SCREEN. THE COVER WAS REMOVED AND MOISTURE CORROSION WAS FOUND INSIDE THE PUMP TO THE PRINTED CIRCUIT BOARD ON THE DISPLAY SCREEN, TO THE CONTINUOUS GLUCOSE MONITORING MODULE, AND TO THE MOTOR FLEX/CONNECTOR. THE KEYPAD WAS REMOVED FOR FURTHER INVESTIGATION AND NO CONTAMINATION WAS FOUND TO THE KEY CONTACTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) 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
    423399 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1