BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3080520 · Received April 26, 2013

    Report

    Report Number
    2531779-2013-05367
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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 WAS FOUND TO BE DIM AND DISCOLORED. A TEST DISPLAY SCREEN WAS INSERTED AND WAS FOUND TO FUNCTION PROPERLY. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE DISPLAY SCREEN WAS DIM AND DIFFICULT TO READ. THE REPORTER DID NOT PROVIDE ANY FURTHER INFORMATION. THIS COMPLAINT IS BEING REPORTED BECAUSE, AT THE TIME OF CONTACT, THE DISPLAY ISSUE REMAINED UNRESOLVED. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182017 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR