BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3913399 · Received July 3, 2014

    Report

    Report Number
    2531779-2014-18932
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 27, 2014
    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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: BLACK BOX AND HISTORY RECORDED 064-0001, 070-0001, AND 078-0004 ALARMS. DURING INVESTIGATION RECEIVED A CS 076 ALARM (REWIND TOLERANCE ERROR). OPENED PUMP AND REMOVED FROM CASE. DISASSEMBLED MOTOR DRIVE ASSEMBLY. TESTED MOTOR ON A 5 VOLT POWER SUPPLY. ABLE TO EASILY STALL MOTOR. UNABLE TO COMPLETE FAILED STEPS DUE TO MOTOR FAILURE. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS FADED AND PINK.

    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) 2014, THE DISTRIBUTOR CONTACTED ANIMAS, ALLEGING A MOTOR ISSUE. THE PISTON STOPPED MOVING COMPLETELY. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391652 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1