BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 4173775 · Received October 15, 2014

    Report

    Report Number
    2531779-2014-29294
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/16/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED ¿REPLACE BATTERY¿ ALARMS DUE TO NORMAL BATTERY WEAR ON 09/28/2014; THERE WAS NO EVIDENCE OF SHORT BATTERY LIFE OBSERVED. THE RETURNED BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. THE PUMP SUCCESSFULLY PERFORMED EZ-PRIME STEPS WITH NO ALARMS OCCURRING. THE PUMP¿S CURRENT DRAWS WERE TESTED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. THE COMPLAINT OF SHORT BATTERY LIFE COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. UNRELATED TO THE COMPLAINT, THE PUMP¿S COVER WAS REMOVED AND AN INTERMITTENT CONDITION WAS FOUND TO THE CGM MODULE DUE TO A COLD SOLDER CONNECTION. ADDITIONALLY, INVESTIGATION REVEALED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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 THAT THE BATTERY LIFE WAS SHORTER THAN EXPECTED. REPORTEDLY THE ISSUE HAD OCCURRED WITH MULTIPLE BATTERIES FROM DIFFERENT PACKS. TROUBLESHOOTING CONFIRMED LOW BATTERY WARNINGS HAD BEEN EMITTED. 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
    655512 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR