BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3875047 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17135
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/01/2014 WITH THE FOLLOWING FINDINGS: THERE WAS NO ACTIVITY OUTSIDE NORMAL PATIENT USE OBSERVED IN PUMP HISTORIES. PUMP HISTORIES SHOW PUMP WAS IN USE UNTIL (B)(4) 2012. NO DEFECT RELATED TO PI FOUND. DISPLAY SCREEN IS DIM; LETTERS HAVE A RED HUE. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    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 AN OTHER (UNUSUAL ISSUE) ISSUE. IT WAS REPORTED THAT THE PATIENT HAS BEEN OFF THE PUMP FOR SEVERAL YEARS AND IS NOW PREGNANT. THE PATIENT¿S HEALTHCARE PROFESSIONAL FEELS THAT THE PUMP IS NOT SAFE TO USE WHILE PREGNANT SINCE THE PUMP HAD NOT BEEN USED IN SEVERAL YEARS. 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
    353096 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR