BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3162107 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08065
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/06/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/15/2013 WITH THE FOLLOWING FINDINGS: DURING TESTING, THE DISPLAY SCREEN TEXT WAS FOUND TO BE DIM/FADED, DISCOLORED AND DIFFICULT TO READ. A TEST SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY WITH NO VISIBLE SIGNS OF FADING OR DISCOLORATION OF TEXT. EVALUATION WAS UNABLE TO DUPLICATE THE COMPLAINT OF THE ¿DISPLAY SHRINKING¿ AND ¿SCREEN TURNING GRAYISH COLOR¿ ISSUE. 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 BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DISPLAY ISSUE) ISSUE. IT WAS REPORTED THAT THE DISPLAY WAS ¿SHRINKING¿ AND THE EDGES WERE BLACK. REPORTEDLY, THE DISPLAY SCREEN WAS ALSO DISCOLORED. 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
    263139 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR