BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3192377 · Received June 27, 2013

    Report

    Report Number
    2531779-2013-09072
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    June 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS:TESTING WAS UNABLE TO DUPLICATE REPORTED ¿LOAD STEP MALFUNCTION¿: PUMP POWERS ¿ON¿ AND DISPLAYS ¿VERIFY¿ SCREEN. THE PUMP PASSED ¿EZ-PRIME¿ STEPS AND PRIMED A FULL CARTRIDGE SUCCESSFULLY. PUMP¿S COVER WAS REMOVED, THE FORCE SENSOR FLEX PINS WERE INSPECTED TO FIND AN INTERMITTENT CONDITION DUE A CRACKED TRACE NEAR TO THE PIN. .FORCE SENSOR RESISTANCE READING IS WITHIN THE REQUIREMENT. FORCE SENSOR CALIBRATION READING IS ABOVE SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THAT THE PUMP DISPENSED INSULIN DURING THE LOAD STEP. 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
    294115 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR