BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3243798 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11782
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE DISPLAY SCREEN WAS CRACKED. THE PATIENT STATED THAT THE DAMAGE WAS NOTICED ON (B)(6) 2013; TRAUMA TO THE PUMP AND EVIDENCE OF MOISTURE OR CONDENSATION IN THE PUMP WAS DENIED. THE PATIENT SAID THAT THE DISPLAY SCREEN INFORMATION COULD BE CLEARLY READ, AND THE PATIENT CONTINUED TO USE THE PUMP UNTIL A REPLACEMENT WAS DELIVERED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. THE COMPLAINT IS BEING REPORTED BECAUSE THE DISPLAY SCREEN COULD NOT BE CORRECTED DURING THE CONTACT WITH ANIMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342936 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR