BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2123646 · Received June 14, 2011

    Report

    Report Number
    2531779-2011-04150
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION NUMBER: 2531779-03/24/2010-003-R. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS 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. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. UNRELATED TO THIS COMPLAINT AND NOT REPORTED BY THE PATIENT, EVALUATION REVEALED AN UNIDENTIFIED DISPLAY SCREEN ISSUE.

    Additional Manufacturer Narrative · 1

    A RETAIN CARTRIDGE FROM THE SAME CARTRIDGE LOT OF CARTRIDGES INVOLVED IN THIS COMPLAINT WAS TESTED ON (B)(4) 2011. THE CARTRIDGE LOT NUMBER WAS B201629. THE CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS OBSERVED TO THE LUER, O-RINGS, PLUNGER, OR CARTRIDGE BODY. A FORCE TEST WAS PERFORMED WITH NO FAILURES AT THE CONCLUSION OF TESTING.

    Description of Event or Problem · 1

    DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR