BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3266471 · Received August 6, 2013

    Report

    Report Number
    2531779-2013-12292
    Event Type
    Injury
    Date Received
    August 6, 2013
    Date of Event
    July 7, 2013
    Report Date
    July 7, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A RETAINED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER B201968 WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION, A FORCE TEST AND A FILL TEST OF THE CARTRIDGE WERE PERFORMED AND NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. 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

    THE CARTRIDGE HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. THE EVENT WAS ATTRIBUTED TO TRAINING/MISUSE OF THE PRODUCT AS TROUBLESHOOTING INDICTED THAT THE EVENT WAS RELATED TO INSERTING A CARTRIDGE FILLED WITH AIR INTO THE PUMP. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 STATING THAT THE PATIENT HAD A BLOOD GLUCOSE OF HI ON THE METER (OVER 600 MG/DL) WITH NO SYMPTOMS. THE REPORTER STATED THAT THE PATIENT WAS GIVEN A CORRECTION USING A SYRINGE AND BLOOD GLUCOSE LEVELS DROPPED TO 70 MG/DL. THE REPORTER STATED THAT HE PUMP WAS NOT DELIVERING INSULIN AND THE PUMP WOULD NOT PRIME RIGHT. CUSTOMER SUPPORT WALKED THE REPORTER THROUGH REMOVING THE CARTRIDGE FROM THE PUMP AND FOUND THAT THE CARTRIDGE WAS FILLED WITH AIR. THE REPORTER STATED THAT THEY MUST HAVE PUT THE OLD CARTRIDGE BACK IN THE PUMP INSTEAD OF THE NEW ONE. THE REPORTER STATED THAT THE PATIENT WOULD HAVE BEEN WITHOUT INSULIN SINCE YESTERDAY RELATED TO THE ISSUE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO INSERTION OF A CARTRIDGE FILLED WITH AIR INTO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367218 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening