BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3202373 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09546
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/02/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED DATA FROM (B)(6) 2013. THE BLACK BOX HISTORY REVEALED MULTIPLE POWER ON RESET (POR) EVENTS THAT OCCURRED ON (B)(6) 2013 AND ON (B)(6) 2013. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE LAST BASAL DELIVERY WAS RECORDED ON (B)(6) 2013. THE PUMP HISTORY INDICATED THAT THE BATTERY VOLTAGE WAS FOUND TO BE ABOVE THE ¿LOW¿ AND ¿REPLACE¿ BATTERY THRESHOLDS PRIOR TO THE ¿POR¿ EVENTS. THE PUMP ALARM HISTORY REVEALED NO "REPLACE BATTERY¿ ALARMS OR ¿LOW BATTERY¿ WARNINGS PRIOR THE "POR" EVENTS. A VISUAL INSPECTION REVEALED NO DAMAGE OR MOISTURE INGRESS TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS FOUND TO BE INTACT AND ABLE TO MAINTAIN ELECTRICAL CONNECTION. THE PUMP SUCCESSFULLY POWERED ON AND DISPLAYED THE ¿VERIFY¿ SCREEN. THE AUDITORY SOUND AND VIBRATORY ALERT FEATURE WERE FOUND TO BE FUNCTIONING WITH NO ISSUES AT THE INITIAL STARTUP OF THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS; NO POWER ISSUES WERE NOTED DURING TESTING. A POWER SUPPLY WAS USED; A ¿LOW BATTERY¿ WARNING AND A ¿REPLACE BATTERY¿ ALARM WERE INDUCED; THE PUMP GAVE THE APPROPRIATE VISIBLE AND AUDIBLE ALERT. THE PUMP¿S COVER WAS REMOVED; NO INTERMITTENT ISSUES OR ELECTRICAL CIRCUIT ISSUES WERE NOTED. THE REPORTED COMPLAINT WAS NOTED IN HISTORY BUT NOT DUPLICATED DURING INVESTIGATION. 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. 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

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) /2013 AND REPORTED A DUAL ALARM FAILURE. THE REPORTER STATED THAT AT THE END OF THE BATTERY LIFE THE PUMP DID NOT EMIT AUDIBLE ALERT SOUNDS OR VIBRATION. 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
    301002 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1