BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3725995 · Received April 3, 2014

    Report

    Report Number
    2531779-2014-08766
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 04/22/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 04/09/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE DISPLAY SCREEN WAS FOUND TO BE DIM AND DISCOLORED. THE KEYPAD COVER WAS FOUND TO BE INTACT; NO DAMAGE WAS OBSERVED. THE UP ARROW AND DOWN ARROW BUTTONS WERE INTERMITTENTLY UNRESPONSIVE DURING TESTING. THE OK AND CONTRAST BUTTONS RESPONDED APPROPRIATELY. THE KEYPAD COVER WAS REMOVED AND EVIDENCE OF CONTAMINATION WAS FOUND UNDERNEATH ALL OF THE KEY CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A DISPLAY (DIM/FADING/COLOR SPECTRUM) ISSUE. THE DISPLAY SCREEN HAS BECOME DIM AND THE TEXT HAS BECOME YELLOW IN COLOR. THE ISSUE BEGAN SEVERAL MONTHS PRIOR TO THE COMPLAINT. 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
    201571 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR