BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2253640 · Received September 19, 2011

    Report

    Report Number
    2531779-2011-06876
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT OCCLUSION ALARMS HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THERE WAS EVIDENCE OF GREEN CONTAMINATION FOUND ON THE FORCE SENSOR SHIM PLATE. EVALUATION REVEALED THAT THE FORCE SENSOR RESISTANCE MEASUREMENT WAS OUT OF CALIBRATION.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR RECURRING OCCLUSION ALARMS. EVALUATION REVEALED CONTAMINATION ON THE FORCE SENSOR PLATE AND THAT THE FORCE SENSOR RESISTANCE MEASUREMENT WAS OUT OF CALIBRATION. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2011.

    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