BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2453788 · Received February 15, 2012

    Report

    Report Number
    2531779-2012-01157
    Event Type
    Malfunction
    Date Received
    February 15, 2012
    Report Date
    October 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 01/19/2012. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/19/2012 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PRIME, LOAD, AND REWIND SEQUENCE WAS PERFORMED WITHOUT DIFFICULTY. LOSS OF PRIME WARNINGS WERE OBSERVED IN THE HISTORY BUT WERE NOT DUPLICATED DURING TESTING. EVALUATION REVEALED THAT THE FORCE RESISTANCE MEASUREMENT WAS OUT OF SPECIFICATION. CONTAMINATION WAS DISCOVERED ON THE FORCE SENSOR PLATE AND THE FORCE SENSOR SHIM WAS SHIFTED. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. 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. (B)(6). CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR INVESTIGATION OF MULTIPLE LOSS OF PRIME WARNINGS. 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 1200 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR