BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2212752 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05919
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    June 9, 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

    CORRECTION NUMBER: 2531779-03/24/2010-003-R. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/13/2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED UP PROPERLY WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. AN EZPRIME OPERATION WAS PERFORMED AND THE PUMP CORRECTLY DETECTED THE CARTRIDGE. THERE WAS EVIDENCE OF CONTAMINATION FOUND ON THE FORCE SENSOR PLATE.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR RECURRING LOSS OF PRIME. EVALUATION REVEALED CONTAMINATION ON THE FORCE SENSOR PLATE. 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 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR