BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4102909 · Received September 19, 2014

    Report

    Report Number
    2531779-2014-26865
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Report Date
    September 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/22/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DID RECORD THAT 6 UNITS WERE PRIMED INTO THE TUBING DURING THE LOAD STEP. THE PUMP WAS LOADED WITH A CARTRIDGE CONTAINING 100 UNITS, AND THEN PERFORMED THE REWIND AND LOAD STEPS WITH NO ISSUE OCCURING. THE FORCE SENSOR WAS FOUND TO BE WITHIN CALIBRATION. NO DEFECTS WERE FOUND WITH THE FORCE SENSOR.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. IT WAS REPORTED THAT THE PUMP PRIMED THE TUBING WITH 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
    585257 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR