BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3854971 · Received June 9, 2014

    Report

    Report Number
    2531779-2014-16116
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 22, 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

    (B)(6). 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

    (B)(4). 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 07/10/2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED UNUSUAL FLUCTUATION OF THE VOLTAGE ON (B)(4) 2014 AT 06:24 WITH THE VOLTAGE SUDDENLY DROPPING FOLLOWED BY ANOTHER SUDDEN DROP IN VOLTAGE AT 08:51. THE BATTERY THAT WAS IN THE PUMP AT THAT TIME WAS NOT RETURNED WITH THE PUMP FOR THE INVESTIGATION; NO BATTERY WAS RETURNED WITH THE PUMP. A NEW ENERGIZER ULTIMATE LITHIUM AA 1.5 VOLT BATTERY WAS USED FOR THE INVESTIGATION AND WAS ABLE TO POWER ON THE PUMP TO THE VERIFY SCREEN WITHOUT ISSUE. ON INVESTIGATION, THE PUMP SUCCESSFULLY PERFORMED A REWIND, LOAD AND PRIME SEQUENCE. THE PUMP WAS TESTED WITH AN EXTERNAL POWER SUPPLY AND ALL CURRENTS WERE FOUND TO BE WITHIN THE REQUIRED SPECIFICATIONS. NO OVERHEATING WAS DUPLICATED DURING TESTING. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION OF THE INTERIOR PUMP COMPONENTS. INVESTIGATION CONFIRMED VOLTAGE FLUCTUATION IN THE HISTORY; HOWEVER, THE TEMPERATURE ISSUE WAS NOT DUPLICATED DURING THE INVESTIGATION AND THE PUMP WAS FOUND TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336112 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1