BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3181339 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08704
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 06/21/2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. BLACK BOX CONTAINS DATA FROM (B)(6) 2013 TO (B)(6) 2013. LAST BASAL DELIVERY IS RECORDED ON (B)(6) 2013. NO BATTERY CHANGE IS OBSERVED IN BLACK BOX , NO ¿REPLACE BATTERY¿ ALARM OR ¿LOW BATTERY¿ WARNINGS ARE OBSERVED. THE BATTERY COMPARTMENT AND CAP ARE INTACT AND ABLE TO MAINTAIN ELECTRICAL CONNECTION. PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. BATTERY CAP CONTACTS MEASUREMENTS WER FOUND WITHIN SPECIFICATION. CAP WAS TIGHTENED AND THEN UNSCREWED ½ TURN, NO REBOOTS OCCURRED .THE UNIT WAS EXERCISED FOR 24H WITH NO POWER INTERRUPTIONS OR ALARMS OCCURRING. ¿LOW BATTERY¿ WARNING AND ¿REPLACE BATTERY¿ ALARMS WERE STIMULATED DURING TESTING; THE PUMP GAVE THE APPROPRIATE AUDIBLE AND VISIBLE ALERTS AND HISTORY RECORDED ACCURATE ALARM AND WARNING INFO AT THE CORRECT TIME AND ORDER. PUMP¿S COVER WAS REMOVED, NO MOISTURE INGRESS WAS OBSERVED. NO INTERMITTENT CONDITION WAS FOUND TO THE POWER CIRCUIT. 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTOR CONTACTED ANIMAS AND ALLEGED THAT THE PUMP IS NOT EMITTING THE LOW/REPLACE BATTERY ALARMS. HAD TO CHANGE HIS BATTERY THREE TIMES AS IT COMES UP WITH A LOW BAR BUT NO WARNING. NO WARNING CAME UP IN HIS HISTORY MENU EITHER. THE PUMP JUST SHUTS DOWN AND THEN HE NEEDS TO REPLACE THE BATTERY. HAS HAPPENED THREE TIMES. THERE IS NO ADVERSE EVENT RELATED TO THIS ISSUE. THIS COMPLAINT IS BEING REPORTED AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282045 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1