BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3649189 · Received February 27, 2014

    Report

    Report Number
    2531779-2014-05560
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/06/2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FORCE TEST WAS PERFORMED WITH NO DEFECTS FOUND. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES OCCURRING; THE CARTRIDGE WAS CYCLED NORMALLY WITH NO DIFFICULTIES FOUND DURING CARTRIDGE FILLING. 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. A RETAIN SAMPLE FROM THE SAME CARTRIDGE LOT WAS ALSO TESTED, WITH NO FAILURES FOUND. A LOT REVIEW WAS PERFORMED WITH NO FAILURES OBSERVED DURING INCOMING INSPECTION. 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. (B)(4). LOT # WAS ORIGINALLY REPORTED AS D2000082. THE CORRECT LOT # FOR THIS DEVICE IS D200028.

    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 ALLEGING THAT THE PATIENT AWOKE WITH A BLOOD GLUCOSE (BG) OF 489MG/DL WITH LARGE KETONES, NAUSEA, VOMITING, AND EXCESSIVE URINATION. THE REPORTER STATED THAT THERE WAS A LARGE AIR BUBBLE IN THE INFUSION SET TUBING. THE REPORTER STATED THAT THE PATIENT WAS GIVEN A CORRECTION INJECTION AND WITHIN AN HOUR BG CAME DOWN TO 385MG/DL. TROUBLESHOOTING INDICATED THAT THE USER WAS PREPARING AND USING CARTRIDGES CORRECTLY PER THE INSTRUCTIONS FOR USE AND WAS AWARE OF HOW TO REMOVE AIR BUBBLES FROM THE SYSTEM. THE REPORTER NOTED THAT THEY HAD BEEN HAVING ONGOING ISSUES WITH AIR BUBBLES IN THE CARTRIDGES DESPITE PROPER FILL TECHNIQUE AND DESPITE TRAINING, AND WAS CONCERNED THAT ONE OF THESE AIR BUBBLES HAD TRAVELED INTO THE TUBING OVERNIGHT AND CAUSED AN ELEVATED BG. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA RELATED TO AIR BUBBLES IN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121936 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION D2000082

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R