BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 3760415 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10602
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 31, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    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 PUMP HAD BEEN POWERED OFF ON MARCH 25, 2014 AND WAS NOT PRIMED WHEN IT WAS SUBSEQUENTLY POWERED ON. THERE WAS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX DATA. NO PRIME ISSUE OCCURRED DURING THE INVESTIGATION AND NO INTERMITTENT CONDITION WAS FOUND TO THE FORCE SENSOR CIRCUIT. INVESTIGATION DID NOT CONFIRM OR DUPLICATE THE ALLEGED PRIME ISSUE AND THE PUMP WAS DETERMINED TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2014 ALLEGING A BATTERY CHANGE AND PRIME ISSUE WITH THE PUMP INVOLVING THE REWIND, LOAD, OR FILL CANNULA STEP. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRIME ISSUE REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240583 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1