BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS VIBE

    MDR report key: 2982142 · Received February 28, 2013

    Report

    Report Number
    2531779-2013-02234
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 04/16/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED WHICH WAS DUPLICATED DURING TESTING. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. INVESTIGATION REVEALED A BROKEN CONNECTION AT THE FORCE SENSOR PIN.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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. (B)(6).

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE DISTRIBUTOR CONTACTED ANIMAS AND REPORTED A PUMP MALFUNCTION, PRIME OTHER LOAD STEP OR CARTRIDGE NOT RECOGNIZED. THIS COMPLAINT IS BEING REPORTED AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE IS NO INDICATION OF AN ADVERSE EVENT RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88156 ANIMAS VIBE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS VIBE INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1