BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3202092 · Received July 2, 2013

    Report

    Report Number
    2531779-2013-09545
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS COMPLAINT HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/05/2013 WITH THE FOLLOWING FINDINGS: INVESTIGATION REVEALED DURING A VISUAL INSPECTION, THE DISPLAY SCREEN WAS CONFIRMED TO HAVE MULTIPLE SCRATCHES. THE DISPLAY SCREEN WAS ALSO FOUND TO BE DIM AND DISCOLORED. A NEW TEST SCREEN WAS INSERTED AND THE DISPLAY SCREEN WAS FOUND TO BE FUNCTIONING AND ILLUMINATED TO NORMAL CONTRAST.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE DISPLAY SCREEN LENS WAS SCRATCHED. AT THE TIME OF TROUBLESHOOTING, THE REPORTER STATED THE DISPLAY WAS SO SCRATCHED THAT HE WAS HAVING TROUBLE SEEING THE DISPLAY. AT THE TIME OF TROUBLESHOOTING, THE PATIENT CONFIRMED THERE WAS NO TRAUMA TO THE PUMP AND THERE WAS NO LENS FILM ON THE DISPLAY 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
    302924 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR