BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3954925 · Received July 24, 2014

    Report

    Report Number
    2531779-2014-21255
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 8/26/14: NO PRODUCT WAS RETURNED. A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 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.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE PATIENT HAD BLOOD GLUCOSE (BG) LEVELS IN THE 300-400 MG/DL RANGE, WITH TIREDNESS AND EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION. DURING TROUBLESHOOTING, CUSTOMER SUPPORT HAD THE PATIENT CHANGE THE CARTRIDGE AND TRY TO COMPLETE PRIME STEP. THE PATIENT WAS ABLE TO PRIME THE PUMP WITHOUT AN OCCLUSION ALARM OR CS064 ALARM OCCURRING OR CHANGE IN MOTOR NOISE. THE CARTRIDGE ISSUE WAS RESOLVED WITH TROUBLESHOOTING AND IS NOT BEING REPORTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434551 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening