BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4130148 · Received September 30, 2014

    Report

    Report Number
    2531779-2014-27922
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/11/2014 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THERE WAS MOISTURE CORROSION ON THE DISPLAY SCREEN INSIDE THE PUMP. A LEAK TEST WAS PERFORMED AND A PUMP CASE LEAK WAS FOUND AT A CRACK BETWEEN THE DISPLAY LENS AND CASE SEAL. THE PUMP WAS COMPLETELY UNRESPONSIVE AND WAS NOT ABLE TO BE POWERED ON. THE PUMP CASE WAS REMOVED AND MOISTURE CORROSION WAS FOUND INSIDE THE PUMP ON THE PRINTED CIRCUIT BOARD, DISPLAY SCREEN, AND OTHER INTERNAL COMPONENTS. NO BATTERY OR CARTRIDGE CAPS WERE RETURNED WITH THE PUMP. TEST CAPS WERE USED TO COMPLETE THE INVESTIGATION. THE COMPLAINT THAT THE DISPLAY SCREEN WAS BLANK WAS NOT ABLE TO BE ADEQUATELY INVESTIGATED DUE TO THE PUMP NOT POWERING ON. 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.

    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)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (BLANK SCREEN W/MOISTURE) ISSUE. THE DISTRIBUTOR ALLEGED THAT, AFTER INSERTING A NEW BATTERY, THE PUMP EMITTED A REPLACE BATTERY ALARM FOLLOWED BY THE DISPLAY GOING BLACK. 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
    608296 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1