BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093744 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26450
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 1, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE EVALUATION WAS COMPLETED FOR A PREVIOUS COMPLAINT ON 12/10/2013, PRIOR TO THE DATE THIS COMPLAINT WHICH WAS REPORTED TO ANIMAS, ON (B)(6) 2014. PRODUCT ANALYSIS FROM THE PREVIOUS INVESTIGATION HAD THE FOLLOWING FINDINGS: THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP AND WAS ABLE TO SUCCESSFULLY MAINTAIN ELECTRICAL CONNECTION. THE PUMP WAS ABLE TO SUCCESSFULLY COMPLETE THE REWIND, LOAD, AND PRIME STEPS. NO ADDITIONAL TESTING COULD BE COMPLETED BECAUSE THE PUMP WAS DISASSEMBLED AS PART OF THE PRIOR TESTING AND THE PUMP WAS NO LONGER AVAILABLE TO FULLY INVESTIGATE THE REPORTED MOTOR ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A MOTOR (MOTOR ISSUE) ISSUE. THE REPORTER STATED THAT THE REWIND AND LOAD STEPS HAD BEEN TAKING MUCH LONGER THAN EXPECTED CAUSING THE PUMP TO GO TO SLEEP AND THEN BACK TO THE HOME SCREEN. 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
    573605 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR