BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4141381 · Received October 3, 2014

    Report

    Report Number
    2531779-2014-28352
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP #2 12/22/2014 - DEVICE EVALUATION: THE CARTRIDGE WAS RETURNED TO ANIMAS AND EVALUATED ON 12/04/2014. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED. A FORCE TEST WAS PERFORMED WITH NO ISSUES OR FAILURES FOUND. 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

    DEVICE EVALUATION:A RETAIN SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST WAS PERFORMED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. THE CARTRIDGE FORCE READINGS WERE CONFIRMED TO BE WITHIN SPECIFICATIONS; NO FAILURES WERE NOTED RELATED TO THE LOSS OF PRIME COMPLAINT. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE, CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION. THE RETAIN CARTRIDGE PASSED A LOT REVIEW.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING MULTIPLE LOSS OF PRIME WARNINGS THAT WERE CLEARED AFTER A CARTRIDGE CHANGE. 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
    620125 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION D200082

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR