BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2932722 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01272
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE PUMP LOAD STEP FAILED TO DETECT THE CARTRIDGE. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND FOUND THAT THE FORCE SENSOR WAS OUT OF CALIBRATION. THE PUMP WAS OPENED AND CONTAMINATION WAS FOUND IN THE FORCE SENSOR ASSEMBLY. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE FADED AND DISCOLORED. (B)(6). CORRECTION/REMOVAL REPORTING NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. INVESTIGATION REVEALED CONTAMINATION IN THE FORCE SENSOR ASSEMBLY AND REVEALED AN OUT OF CALIBRATION FORCE SENSOR. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39487 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1