BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2933788 · Received January 29, 2013

    Report

    Report Number
    2531779-2013-01317
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX SHOWED EVIDENCE THAT LOSS OF CARTRIDGE DETECTION HAD OCCURRED. DURING THE PUMP LOAD CARTRIDGE PHASE, THE PUMP WAS UNABLE TO DETECT THE FILLED CARTRIDGE. A FORCE SENSOR CALIBRATION TEST WAS PERFORMED AND THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. THE PUMP WAS OPENED AND A FORCE SENSOR CIRCUIT COMPONENT ON THE PRINTED CIRCUIT BOARD WAS FOUND TO BE MISALIGNED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO ANIMAS. INVESTIGATION FOUND AN OUT OF CALIBRATION FORCE SENSOR AND A MISALIGNED FORCE SENSOR CIRCUIT COMPONENT. THIS REPORT IS MADE BASED ON THE RESULTS OF INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38758 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1