BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 6184990 · Received December 19, 2016

    Report

    Report Number
    2531779-2016-34150
    Event Type
    Injury
    Date Received
    December 19, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    UDI-DI
    10840406100129
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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

    FOLLOW-UP #1 SUBMITTED 01/30/2017. DEVICE EVALUATION: NO PRODUCT WAS RETURNED. A RESERVED SAMPLE OF THE SAME CARTRIDGE LOT NUMBER # D200359 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE RETAINED CARTRIDGE SAMPLE WAS FOUND TO PASS THE VISUAL INSPECTION AND THE FILL, FORCE, AND LEAK TESTING. NO DEFECTS WERE FOUND RELATED TO LOSS OF PRIME. 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

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED A BLOOD GLUCOSE READING OF 441 MG/DL WITH NAUSEA, EXTREME THIRST, AND A LARGE LEVEL OF KETONES ASSOCIATED WITH AN OCCLUSION ALARM. IT WAS REPORTED THAT THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT AND REMAINED ON INSULIN PUMP THERAPY. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT, IT WAS DETERMINED THAT THE PATIENT WAS NOT USING THE CARTRIDGE ACCORDING TO THE INSTRUCTIONS FOR USE. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ASSOCIATED WITH USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837069 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D200359 10840406100129

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Life Threatening