BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3091572 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05830
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 9, 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

    FOLLOW-UP #1 DATE OF SUBMISSION 07/12/2013 DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/12/2013 WITH THE FOLLOWING FINDINGS: EVALUATION SHOWED NO EVIDENCE OF LOAD STEP MALFUNCTION IS OBSERVED IN THE BLACK BOX AND MULTIPLE PERSISTENT ¿CS064-0001¿ALARMS ARE OBSERVED ON THE REPORTED FAILURE DATE. THE PUMP POWERS ON AND DISPLAYS VERIFY SCREEN. THE PISTON WAS UNABLE TO PERFORM ANY MOVEMENT, UNABLE TO COMPLETE ¿EZ-PRIME¿ STEPS. INVESTIGATORS WERE UNABLE TO TAKE FORCE SENSOR CALIBRATION READING AND ADEQUATELY INVESTIGATE REPORTED LOAD STEP MALFUNCTION. PUMP WAS OPENED AND INSPECTED, NO DEFECT WAS FOUND TO THE FORCE SENSOR CIRCUIT. A PCB INSPECTION SHOWS NO MOISTURE CORROSION. THE INTERNAL MOTOR WAS TESTED AND IT WAS FOUND DEFECTIVE, NO DEFECT WAS FOUND TO THE DRIVE ASSEMBLY.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE DISTRIBUTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE PUMP REPORTEDLY DID NOT DETECT THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193712 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1