BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSULIN INFUSION PUMP

    MDR report key: 5876561 · Received August 15, 2016

    Report

    Report Number
    2531779-2016-21019
    Event Type
    Other
    Date Received
    August 15, 2016
    Report Date
    July 19, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING A CRACKED/DAMAGED CASING CONDITION ISSUE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP TYPE REPORTEDLY WAS UNKNOWN AT THE TIME THE INCIDENT WAS REPORTED. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS COMPLAINT. THIS IS REPORTABLE AS THE ALLEGED MALFUNCTION HAS THE ABILITY TO RESULT IN A DELAY IN TREATMENT OR LONG TERM CESSATION IN DELIVERY IF THE DAMAGE IMPACTS THE POWER CIRCUIT OR CARTRIDGE COMPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528976 INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female