BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3771869 · Received April 24, 2014

    Report

    Report Number
    2531779-2014-11314
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE CARTRIDGE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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

    (B)(4)-DEVICE EVALUATION: THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. A RETAIN SAMPLE FROM THE SAME LOT OF CARTRIDGE WAS TESTED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE RETAIN CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST, A FORCE TEST AND A LEAK TEST WERE PERFORMED ON THE RETAIN SAMPLE AND IT MET PASSING CRITERIA. THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS; NO FAILURES RELATED TO THE LOSS OF PRIME COMPLAINT WERE NOTED. 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. A REVIEW OF INCOMING INSPECTION RECORD INDICATED THAT THE LOT MET RELEASE CRITERIA.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (AIR BUBBLES/LEAK) ISSUE. REPORTEDLY, THERE WAS AN ISSUE WITH AIR BUBBLES IN THE CARTRIDGE. THE REPORTER STATED THAT THE LURE LOCK WAS SECURED BETWEEN THE INFUSION SET AND CARTRIDGE. REVIEW OF FILLING TECHNIQUES INDICATED THAT THE FILLING INSTRUCTION FOR USE WAS FOLLOWED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249936 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B202053

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR