BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3811494 · Received May 15, 2014

    Report

    Report Number
    2531779-2014-13565
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED RECORDS OF CALL SERVICE ALARMS. ON EXAMINATION, THE DISPLAY LENS WAS FOUND TO BE DEEPLY SCRATCHED ON THE TOP OF THE SCREEN. ON INVESTIGATION, THE DISPLAY WAS CLEAR AND WITHOUT DISCOLORATION. NO INK SPOTS WERE OBSERVED ON THE DISPLAY SCREEN. DURING TESTING, THE PUMP EMITTED A CALL SERVICE ALARM WHEN POWERED ON. A SINGLE COMPONENT FAILURE ON THE PRINTED CIRCUIT BOARD WAS IDENTIFIED TO BE THE CAUSE OF THE ALARM. THE COMPONENT WAS REPLACED AND THE CALL SERVICE ALARM ON START-UP WAS RESOLVED.

    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).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (INK SPOTS) 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
    290001 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1