BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3872666 · Received June 13, 2014

    Report

    Report Number
    2531779-2014-16778
    Event Type
    Malfunction
    Date Received
    June 13, 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 (B)(4) 2014 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX DATA REVEALED THE LAST BASAL DELIVERY WAS RECORDED ON (B)(6) 2014; THE REPORTED DATE OF THE EVENT ((B)(6) 2014) WAS OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THERE WERE NO RECORDS OF WARNINGS/ALARMS TO REPLACE THE CARTRIDGE IN THE ALARM HISTORY. ON INVESTIGATION, AN EMPTY CARTRIDGE SCENARIO WAS SIMULATED AND THE PUMP EMITTED THE APPROPRIATE ALERT. THE CARTRIDGE WAS REPLACED CORRECTLY AND NO ¿PRIME¿ STEP WAS REQUIRED PRIOR TO THE ¿REWIND¿ STEP AS ALLEGED. INVESTIGATION DID NOT CONFIRM OR DUPLICATE THE REPORTED ISSUE AND THE PUMP WAS FOUND TO BE OPERATING WITH THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING THAT EACH TIME A CARTRIDGE IS EMPTIED AND NEEDS TO BE REPLACED, THE PUMP PROMPTS THE USER TO PRIME THE PUMP AND PERFORM THE PRIME STEPS BEFORE THE PUMP WILL REWIND. THERE WAS NO REPORTED IMPACT TO THE PATIENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349283 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR