BEUDAMED
    FDA Adverse Event Summary report: N

    ANIMAS VIBE

    MDR report key: 3855015 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16179
    Date Received
    June 9, 2014
    Report Date
    May 21, 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

    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 08/25/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED MULTIPLE RECORDS OF CALL SERVICE ALARMS. ON INVESTIGATION, THE PUMP POWERED ON AND EMITTED A CALL SERVICE ALARM. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED A SINGLE COMPONENT FAILURE ON THE PRINTED CIRCUIT BOARD. THE FAILED COMPONENT WAS REPLACED; THE PUMP POWERED ON NORMALLY WITHOUT EMITTING A CALL SERVICE ALARM.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A CALL SERVICE ALARM ISSUE ON (B)(6) 2014. THERE WAS NO REPORTED IMPACT TO THE PATIENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED CALL SERVICE ALARM ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335514 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1