BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3981541 · Received August 5, 2014

    Report

    Report Number
    2531779-2014-22464
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/22/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/20/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A REVIEW OF THE PUMP HISTORY REVEALED THAT THE PUMP WAS IN USE UNTIL 06/25/2014. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. THE PUMP PASSED THE DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE REPORTED INACCURATE DELIVERY ISSUE WITH THE PUMP WAS NOT CONFIRMED OR DUPLICATED DURING TESTING. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND THE TEXT HAD A RED HUE. 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

    (B)(6). 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE DISTRIBUTER CONTACTED ANIMAS AND REPORTED AN INACCURATE DELIVERY ISSUE WITH THE PUMP. IT WAS INDICATED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE; NO BG VALUES WERE REPORTED. THE PATIENT REPORTEDLY REMAINED CONNECTED TO THE PUMP THROUGHOUT THE NIGHT. IT WAS NOTED THAT THE PATIENT CHANGED THE CARTRIDGE AND THE INFUSION SET. TROUBLESHOOTING THE PUMP INDICATED THE FOLLOWING: THERE WERE NO ALARMS ASSOCIATED WITH THE REPORTED EVENT, THERE WAS NO INDICATION OF A PROGRAMMING/SETTINGS ISSUES NOTED WITH THE PUMP AND THERE WAS NO PRIME OR DELIVERY ISSUES WITH THE PUMP. CUSTOMER TECHNICAL SUPPORT HAS MADE MULTIPLE ATTEMPTS TO TRY AND OBTAIN ADDITIONAL INFORMATION AND IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP TO THIS REPORT WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457124 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1