BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3926462 · Received July 10, 2014

    Report

    Report Number
    2531779-2014-19544
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    June 24, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/01/2014 WITH THE FOLLOWING FINDINGS: CONSECUTIVE CALL SERVICE ALARMS WERE OBSERVED IN THE BLACK BOX ON (B)(4) 2014. THE BATTERY AND CARTRIDGE CAPS WERE NOT RETURNED; TEST BATTERY AND CARTRIDGE CAPS WERE USED TO COMPLETE TESTING. NO CALL SERVICE ALARM OR ANY OTHER WARNINGS OCCURRED DURING THE INVESTIGATION. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE CALL SERVICE ALARM COMPLAINT. THE PRODUCT PERFORMED WITHIN SPECIFICATION. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION AND NO INTERMITTENT CONDITION WAS FOUND TO THE PRINTED CIRCUIT BOARD OR INTERNAL CIRCUITS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 052/053/054/055 SLEEP) ISSUE. IT WAS ALLEGED THAT THE ALARM HAD EMITTED THREE TIMES IN THE PAST THIRTY DAYS. 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
    404121 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1