BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4213568 · Received October 30, 2014

    Report

    Report Number
    2531779-2014-30882
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON 11/06/2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. A VISUAL INSPECTION, A FORCE TEST AND A LEAK TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION. A LOT REVIEW WAS PERFORMED AND NO FAILURES WERE OBSERVED DURING INCOMING INSPECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PUMP HAD REP LOST PRIME MULTIPLE TIMES AND THE PATIENT HAD A BLOOD GLUCOSE OF 475 MG/DL WITH POLYDIPSIA AND POLYURIA. PATIENT SELF TREATED WITH INSULIN VIA PUMP AND INJECTIONS. DURING TROUBLESHOOTING, CUSTOMER SUPPORT (CS) FOUND THAT THE CARTRIDGES WERE BEING USED PER IFU AND THE CARTRIDGE CAP WAS SECURE. CS ADVISED PATIENT TO DISCONTINUED PUMP USE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE LOSS OF PRIME ISSUE WITH THE CARTRIDGE WAS NOT RESOLVED AND THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696007 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200066

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening