BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 5466865 · Received February 29, 2016

    Report

    Report Number
    2531779-2016-04856
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Report Date
    February 3, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #2: DATE OF SUBMISSION: 04/19/2016. DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/31/2016 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSED VISUAL INSPECTION WITH NO EVIDENCE OF ANY DAMAGE OR DEFECTS. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES OCCURRING. THE CARTRIDGE WAS CYCLED NORMALLY WITH NO ISSUES. A LEAK TEST WAS PERFORMED AND NO LEAKS WERE OBSERVED. THE COMPLAINT OF AN AIR BUBBLE ISSUE COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: SUBMITTED 03/15/2016. DEVICE EVALUATION: NO PRODUCT WAS RETURNED. A RESERVED SAMPLE OF THE SAME CARTRIDGE LOT NUMBER # U200114 WAS EVALUATED AND TESTED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: INCOMING INSPECTION OF THE LOT WAS PERFORMED AND NO FAILURES WERE FOUND. THE RETAINED CARTRIDGE SAMPLE WAS FOUND TO PASS THE VISUAL INSPECTION AND THE FILL, FORCE, AND LEAK TESTING. NO DEFECTS WERE FOUND RELATED TO AIR BUBBLES. 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 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) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (AIR BUBBLES/LEAK) ISSUE. THE REPORTER STATED THAT AN AIR BUBBLE ISSUE HAD OCCURRED WITH ONE CARTRIDGE. TROUBLESHOOTING INDICATED THAT THE PATIENT WAS USING CORRECT CARTRIDGE FILL TECHNIQUE. 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
    124608 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION U200114

    Patients

    Seq Age Sex Outcome Treatment
    1