BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230414 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11047
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    July 9, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE NOT YET BEEN RETURNED. IF THE PRODUCT(S) ARE RETURNED, ANM WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/06/2013 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 SIGNS OF FADING OR DISCOLORATION OF TEXT. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A HOLE IN THE AUDIO BOLUS BUTTON COVER. THE AUDIO BOLUS BUTTON RESPONDED APPROPRIATELY TO BUTTON PRESSES. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED AN UNRESPONSIVE VIBRATION MOTOR. THE PUMP WAS OPENED FOLLOWED BY TESTING OF THE VIBRATION MOTOR. TESTING CONFIRMED THAT THE VIBRATION MOTOR WAS INOPERABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A DIM AND FADING DISPLAY ISSUE. THE SCREEN BEGAN GRADUALLY FADING APPROXIMATELY 4 WEEKS 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
    327941 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR