BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3191667 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09066
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    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) 2013, THE LAY-USER/REPORTER CONTACTED ANIMAS, ALLEGING A PROBLEM WITH THE PUMP. THERE WAS NO INFORMATION ABOUT THE ALLEGED DEFECT. ANIMAS HAS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT BACK FOR MORE INFORMATION. A LETTER WAS SENT TO THE PATIENT, REQUESTING A CALL BACK. THERE WAS NO REPORT ANY PATIENT IMPACT. THIS COMPLAINT IS BEING REPORTED DUE TO THE UNRESOLVED PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290432 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR