BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3251868 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12005
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED EVIDENCE OF A LOAD STEP MALFUNCTION ON THE REPORTED EVENT DATE WITH NO CARTRIDGE DETECTED AND LOSS OF PRIME DUE TO ZERO FORCE WARNINGS. DURING TESTING, THE PUMP POWERED ON AND DISPLAYED THE VERIFY SCREEN. THE PUMP PASSED THE EZ PRIME STEPS AND WAS ABLE TO LOAD AND PRIME A CARTRIDGE SUCCESSFULLY. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP COVER WAS OPENED AND NO DAMAGE WAS FOUND TO INTERNAL CIRCUIT BOARD. THE COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THAT THE PUMP PUSHED ALL THE INSULIN OUT DURING THE LOAD STEP AND EMITTED A NO CARTRIDGE DETECTED ALARM. 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
    353271 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR