BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3440116 · Received October 31, 2013

    Report

    Report Number
    2531779-2013-19191
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Report Date
    October 21, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/09/2014 WITH THE FOLLOWING FINDINGS: THERE WERE MULTIPLE 078-0008 ALARMS OBSERVED IN THE BLACK BOX ON THE REPORTED FAILURE DATE OF (B)(6) 2013. TIME AND DATE WAS ACCURATELY SET AT START OF INVESTIGATION. CANNOT PERFORMED PUMP REWIND, LOAD, AND PRIME DUE TO CS 078-0008. THE PUMP WAS OPENED FOR FURTHER INVESTIGATION, INSPECTED THE MOTOR ASSEMBLY AND TESTED THE INTERNAL MOTOR, DEFECT FOUND. THE MOTOR FLEX CABLE HAS AN OPEN TRACE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A CALL SERVICE ALARM (CS 078) ISSUE. 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
    561195 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR