BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4171653 · Received October 14, 2014

    Report

    Report Number
    2531779-2014-29177
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    October 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/01/2014 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED BLACK BOX SHOWS MULTIPLE CONSECUTIVE ¿LOAD¿ STEP OPERATIONS. THERE WERE LARGE PRIME VOLUMES OBSERVED IN THE PRIME HISTORY ON (B)(6) 2014 WITH 17U, AND ON (B)(6) 2014 WITH 28U. THE DISPLAY CONTRAST IS DIM AND REDDISH UPON START UP. THE 100U CARTRIDGE WAS CORRECTLY LOADED AND DISPLAYED, THE PUMP STOPS WITHIN +/-2.5U OF 100U. INVESTIGATORS WERE UNABLE TO DUPLICATE ¿LARGE PRIME VOLUME¿ COMPLAINTS. THERE WAS NO DEBRIS FOUND TO THE CARTRIDGE COMPARTMENT. THE FORCE SENSOR CALIBRATION READING IS BELOW SPECIFICATIONS. THE FORCE SENSOR WAS DISASSEMBLED, CONTAMINATION WAS FOUND TO THE FORCE SENSOR PLATE AND THE FORCE SENSOR RESISTANCE READING IS ABOVE SPECIFICATIONS. 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).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. EVALUATION REVEALED THE DISPLAY WAS DIM AND REDDISH UPON START UP AND THERE WAS CONTAMINATION FOUND ON THE FORCE SENSOR PLATE. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON 10/01/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650380 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR