BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2911665 · Received January 11, 2013

    Report

    Report Number
    2531779-2013-00570
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 18, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. THE REPORTER INDICATED THAT REFRIGERATED INSULIN WAS USED IN THE CARTRIDGE WITHOUT ALLOWING THE INSULIN TO COME UP TO ROOM TEMPERATURE. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: (B)(4) 2013 - NO PRODUCT WAS RETURNED FOR DISPOSITION. A RETAINED CARTRIDGE SAMPLE FROM LOT # B201866 WAS EVALUATED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST, FILL TEST, AND FORCE TEST WAS PERFORMED WITH NO FAILURES OBSERVED. 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) 2012 REPORTING BLOOD GLUCOSE LEVELS OF 500-600 MG/DL OVER THE PAST FEW NIGHTS; THE REPORTER INDICATED THAT ON ONE OF THE NIGHTS THE PATIENT EXPERIENCED NAUSEA RELATED TO THE ELEVATED BLOOD GLUCOSE LEVELS. THE REPORTER STATED THAT THE BLOOD GLUCOSE LEVELS WERE RUNNING FINE DURING THE DAY BUT WOULD ELEVATE IN THE EVENINGS AND AIR BUBBLES WERE FOUND IN THE CARTRIDGE. THE REPORTER INDICATED THAT REFRIGERATED INSULIN WAS USED IN THE CARTRIDGE WITHOUT ALLOWING THE INSULIN TO COME TO ROOM TEMPERATURE. AIR BUBBLE PREVENTION TIPS WERE REVIEWED WITH THE REPORTER. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO USE OF COLD INSULIN IN THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17195 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201866

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening