BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2925228 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-01001
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 27, 2012
    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 PRODUCT WAS RETURNED TO ANIMAS AND WAS INVESTIGATED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX HISTORY REVEALED THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. DURING THE LOAD CARTRIDGE STEP, THE PUMP FAILED TO DETECT THE CARTRIDGE. DURING EVALUATION THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED AND A FORCE SENSOR CIRCUIT COMPONENT WAS FOUND TO BE DISLODGED ON THE PRINTED CIRCUIT BOARD. (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR RECURRING LOSS OF PRIME WARNINGS. INVESTIGATION FOUND THAT A DISLODGE FORCE SENSOR CIRCUIT COMPONENT AND 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
    30164 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1