BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3082140 · Received April 29, 2013

    Report

    Report Number
    2531779-2013-05461
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 19, 2012
    Report Date
    April 4, 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

    (B)(6). (B)(4). DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED DATA RECORDED FROM (B)(6) 2012. THE BLACK BOX RECORDS INCLUDED "NO CARTRIDGE DETECTED" WARNINGS. ON TESTING, THE PUMP WAS EXERCISED FOR (B)(4) WITHOUT LOSS OF PRIME OR PRIME-RELATED WARNINGS. THE FORCE SENSOR WAS EVALUATED AND FOUND TO BE CALIBRATED WITHIN SPECIFICATIONS. DURING THE LOAD STEP, THE PUMP WAS UNABLE TO DETECT THE CARTRIDGE AND CONTINUED TO PUSH FLUID OUT OF THE CARTRIDGE UNTIL THE "CARTRIDGE NOT DETECTED" WARNING WAS DISPLAYED. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED A MISALIGNED FORCE SENSOR CIRCUIT COMPONENT ON THE PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2013: THERE WAS A MISALIGNED FORCE SENSOR COMPONENT ON THE PRINTED CIRCUIT BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184003 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1