BEUDAMED
    FDA Adverse Event Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3190276 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09008
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/20/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/29/2013 WITH THE FOLLOWING FINDINGS: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. THE DISPLAY LENS WAS OBSERVED TO BE HEAVILY SCRATCHED, OBSTRUCTING THE VIEW OF THE SCREEN. DURING TESTING, THE TEXT ON THE DISPLAY WAS DIM/FADED AND DISCOLORED. WHEN REPLACED WITH A TEST DISPLAY, THE SCREEN FUNCTIONED PROPERLY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER'S WIFE CONTACTED ANIMAS AND ALLEGED THAT THE DISPLAY SCREEN IS SO SCRATCHED THAT IS VERY HARD TO FOR THE PATIENT TO READ. THE PUMP DOES NOT HAVE A LENS FILM. THERE IS NO ALLEGATION OF AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED AS THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289575 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR