BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2454457 · Received February 16, 2012

    Report

    Report Number
    2531779-2012-01163
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Report Date
    October 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/19/2012. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION THE REWIND, LOAD, AND PRIME SEQUENCE WAS COMPLETED SUCCESSFULLY. THE ORIGINAL COMPLAINT OF LARGE PRIME VOLUME COULD NOT BE VERIFIED OR DUPLICATED. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION AND THE FORCE RESISTANCE MEASUREMENT WAS OUT OF SPECIFICATION. CONTAMINATION WAS OBSERVED ON THE FORCE SENSOR SHIM. 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.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THAT THE FORCE SENSOR WAS OUT OF CALIBRATION AND THE FORCE RESISTANCE MEASUREMENT WAS OUT OF SPECIFICATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/19/2012.

    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 16 YR