BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2940346 · Received February 3, 2013

    Report

    Report Number
    2531779-2013-01448
    Event Type
    Malfunction
    Date Received
    February 3, 2013
    Report Date
    January 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. A RESERVED SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED WITH NO DAMAGE OR DEFECTS WERE NOTED. A FILL, FORCE AND LEAK 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.

    Additional Manufacturer Narrative · 1

    THE SUBJECT CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS AT THE TIME OF THIS REPORT. 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. IF THE INSULIN CARTRIDGE 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

    THE REPORTER (PATIENT'S FATHER) CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING INSULIN HAD LEAKED FROM THE INSULIN CARTRIDGE INTO THE CARTRIDGE COMPARTMENT. THE PATIENT REPORTEDLY HAD BLOOD GLUCOSE (BG) OF 474 MG/DL WITHOUT SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA OR KETONES. THE REPORTED BG ELEVATION DOES NOT MEET ANIMAS; CRITERIA OF A REPORTABLE ADVERSE EVENT. THE CARTRIDGE WAS CONFIRMED NOT TO BE EXPIRED. THE REPORTER VERIFIED THAT THERE WAS CRYSTALLIZED LIQUID IN THE CARTRIDGE COMPARTMENT. THE REPORTER DENIED LEAKING AT THE LUER LOCK CONNECTION OF THE CARTRIDGE AND TUBING. THE REPORTER DENIED VISIBLE DAMAGE TO THE CARTRIDGE; HOWEVER, DID STATE THAT HE NOTED THE BOX OF CARTRIDGES BEING USED SEEMED TO HAVE AN ISSUE WITH THE PLUNGERS MOVING MORE FREELY THAN WITH PRIOR BOXES OF CARTRIDGES. THE REPORTER NOTED SEEING AIR BUBBLES IN THE CARTRIDGE AS WELL. ANIMAS CUSTOMER TECHNICAL SUPPORT REVIEWED THE REPORTER'S TECHNIQUE FOR PREPARING THE CARTRIDGE FOR FILLING AND DETERMINED THERE WAS NO ISSUE WITH THE PREPARATION TECHNIQUE. THERE WAS NO REPORTED ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED CARTRIDGE AIR BUBBLES AND LEAK REMAINED UNRESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45742 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR