BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 4402605 · Received January 9, 2015

    Report

    Report Number
    2531779-2015-00748
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Report Date
    December 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE RETURNED CARTRIDGE LOT U200032 WAS TESTED BY PRODUCT ANALYSIS ON 02/05/2015 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED; NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE; THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND FILLING THE CARTRIDGE. THE CARTRIDGE PASSED THE FORCE TEST. A LEAK TEST WAS ALSO PERFORMED WITH NO FAILURES; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ANYWHERE ELSE IN THE CARTRIDGE. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 02/02/2015. DEVICE EVALUATION: THE PRODUCT HAS NOT BEEN RETURNED. A RESERVED SAMPLE FROM THE SAME LOT NUMBER U200032 WAS TESTED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED; NO DAMAGE OR DEFECTS WERE NOTED. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE; THE CARTRIDGE CYCLED NORMALLY AND NO DIFFICULTIES WERE FOUND FILLING THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ANYWHERE ELSE IN THE CARTRIDGE. THE CARTRIDGE ALSO PASSED THE FORCE TEST. 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 THAT THE PATIENT EXPERIENCED AN AIR BUBBLE ISSUE WITH MULTIPLE CARTRIDGES AND SUBSEQUENTLY EXPERIENCED HYPERGLYCEMIA. NO BLOOD GLUCOSE (BG) VALUES OR SIGNS OR SYMPTOMS OF HYPERGLYCEMIA WERE PROVIDED. THERE WAS NO MENTION OF MEDICAL INTERVENTION ASSOCIATED WITH THE ALLEGED HYPERGLYCEMIA. THE REPORTER NOTED THAT WHEN THE PATIENT CHANGED TO A CARTRIDGE FROM A DIFFERENT LOT NUMBER, THERE WERE NO FURTHER ISSUES WITH AIR BUBBLES. THE ALLEGED BG EXCURSION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED AIR BUBBLE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20691 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION U200032

    Patients

    Seq Age Sex Outcome Treatment
    1