BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 4251198 · Received November 14, 2014

    Report

    Report Number
    2531779-2014-32676
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING A DIM/FADING/COLOR SPECTRUM DISPLAY ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED AND TROUBLESHOOTING WAS UNABLE TO BE COMPLETED. THERE IS NO INDICATION THAT THE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE REMAINED UNRESOLVED. THIS IS A LATE MDR SUBMISSION DUE TO A SOFTWARE ISSUE THAT HAS BEEN REVIEWED WITH THE FDA IN NOVEMBER 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738301 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR