BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2901135 · Received January 8, 2013

    Report

    Report Number
    2531779-2013-00338
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    December 12, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    FOLLOW-UP #1: (B)(6) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THERE WERE NO ALARMS IN THE PUMP HISTORY RELATED TO THE COMPLAINT. AN EZPRIME OPERATION WAS PERFORMED WITH NO DIFFICULTIES. THE PUMP WAS TESTED ON ALL SETTINGS WITH NO PROBLEM. DURING TESTING THE PUMP ALARMED APPROPRIATELY ABOVE 3.1 MMOL/L WITH NO ISSUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT ANY PROBLEMS BEING DUPLICATED.

    Description of Event or Problem · 1

    THE DISTRIBUTOR CONTACTED ANIMAS ON (B)(6) 2012, ALLEGING THE PUMP CGM LOW BG ALARM DOES NOT GO OFF AT 3.1 MMOL/L (55.8 MG/DL) AS IT SHOULD. THE PATIENT DID NOT HAVE A HIGH BG ALERT SET SO IT IS UNCERTAIN IF THAT FUNCTION WAS WORKING PROPERLY. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ALARM MALFUNCTION REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9547 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1