BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 6479255 · Received April 10, 2017

    Report

    Report Number
    2531779-2017-07414
    Event Type
    Injury
    Date Received
    April 10, 2017
    Report Date
    March 21, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100129
    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 DEVICE 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. 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.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A RETAINED SAMPLE OF THE SAME CARTRIDGE LOT NUMBER D200237 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: A LOT REVIEW INVESTIGATION OF THE INCOMING CARTRIDGES PER LOT WAS COMPLETED PRIOR TO RELEASE OF THIS LOT AND ENSURED THAT ALL CARTRIDGES PASSED FOR THIS LOT. THE RETAINED CARTRIDGE SAMPLE WAS FOUND TO PASS THE VISUAL INSPECTION AND THE FILL, FORCE, AND LEAK TESTING. NO DEFECTS WERE FOUND. 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.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2017 ALLEGING THAT ON (B)(6) 2017 THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASURING 530 MG/DL. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED THE EVENT WAS ASSOCIATED WITH AIR BUBBLES IN THE CARTRIDGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY ASSOCIATED WITH AIR BUBBLES IN THE CARTRIDGE. PRODUCT RETURN TO MANUFACTURER FOR INVESTIGATION WAS REFUSED; CUSTOMER CHOOSES NOT TO RETURN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258246 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION 10840406100129

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening