BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3190444 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09013
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    FOLLOW UP #1 SUBMITTED: 09/10/2013. DEVICE EVALUATION: REVIEW OF THE BLACK BOX DATA REVEALED NO ERRORS, ALARMS OR WARNINGS RELATED TO THE COMPLAINT. THERE WAS A RECORD OF ¿POWER ON RESET¿ ON (B)(4) 2013 AT 15:42. ON EXAMINATION, THE BATTERY COMPARTMENT WAS INTACT WITHOUT DAMAGE OR MOISTURE CONTAMINATION. THE BATTERY CAP RETURNED WITH THE PUMP FOR INVESTIGATION WAS ABLE TO BE FULLY TIGHTENED AND WAS DETERMINED TO MEASURE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER LOSS OR BATTERY-RELATED WARNINGS. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED NO DAMAGE, DEFECT OR CONTAMINATION INSIDE THE PUMP. INVESTIGATION WAS UNABLE TO DUPLICATE THE COMPLAINT OF INTERMITTENT POWER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP HAS BEEN INTERMITTENTLY POWERING OFF. THE REPORTER STATED THE PUMP DOES NOT EMIT AN ALARM, BUT WILL SHUT OFF AND THEN IMMEDIATELY REBOOT. 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
    290892 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR