BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3702160 · Received March 26, 2014

    Report

    Report Number
    2531779-2014-07865
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Report Date
    March 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT LOT NUMBER IS B200021, NOT D200021 AS PREVIOUSLY REPORTED.

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (UNEXPLAINED LOSS OF PRIME) ISSUE. THE REPORTER STATED THAT THE PUMP EMITTED LOSS OF PRIME WARNINGS. CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE USER TO USE A CARTRIDGE FROM A NEW BOX AND CALL BACK IF THE PROBLEM PERSISTS. 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
    177547 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION B200021

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR