BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3241967 · Received July 22, 2013

    Report

    Report Number
    2531779-2013-11657
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    July 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2013 WITH THE FOLLOWING FINDINGS: THERE WAS NO MOISTURE VISIBLE FROM THE OUTSIDE OF THE PUMP. THE PUMP POWERED ON WITH A FADED AND DISCOLORED DISPLAY SCREEN. THE DISPLAY SCREEN WAS REPLACED WITH A TEST SCREEN AND THE DISPLAY RETURNED TO NORMAL. A LEAK TEST WAS PERFORMED AND FOUND A DISPLAY LENS LEAK. THE PUMP WAS OPENED AND EVIDENCE OF MOISTURE WAS FOUND INSIDE THE PUMP CASE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DAMAGED DISPLAY ISSUE. THE PUMP DISPLAY IS SCRATCHED AND CLOUDY; MOISTURE WAS NOTED BEHIND THE DISPLAY. 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
    340404 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR