BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4120229 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27489
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: 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. DURING TESTING, THE PUMP DID NOT RECOGNIZE THE CARTRIDGE DURING AN ATTEMPTED LOAD STEP. THE FORCE SENSOR CALIBRATION WAS LOW AND NOT WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED, AND THE FORCE SENSOR RESISTANCE WAS HIGH AND NOT WITHIN SPECIFICATIONS. CONTAMINATION WAS FOUND ON THE FORCE SENSOR PLATE, AND THE FORCE SENOR PLATE WAS ALSO OBSERVED TO BE DIMPLED. (B)(6).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED A FORCE SENSOR THAT WAS OUT OF CALIBRATION AND DAMAGE TO THE FORCE SENSOR ASSEMBLY. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601710 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR