BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3222906 · Received July 12, 2013

    Report

    Report Number
    2531779-2013-10464
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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, REPORTER CLAIMED THE ANIMAS INSULIN PUMP IS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. ANIMAS ATTEMPTED TO CONTACT THE REPORTER BACK FOR MORE INFORMATION. 3 ATTEMPTS WERE MADE TO CONTACT THE REPORTER. A LETTER WAS SENT TO THE PATIENT, REQUESTING A CALL BACK. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE INACCURATE INSULIN DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321713 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR