BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 3163093 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08104
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CARTRIDGE WAS EVALUATED BY PRODUCT ANALYSIS ON 08/16/2013 WITH THE FOLLOWING FINDINGS: THE RETURNED CARTRIDGE PASSED VISUAL INSPECTION WITH NO DAMAGE OR DEFECTS NOTED IN THE LUER CONNECTION OR O-RINGS. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED. THERE WERE NO LEAKS OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS BEEN RETURNED BUT NOT YET EVALUATED. A RETAIN CARTRIDGE FROM THE SAME LOT HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON 07/11/2013 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A SITE/SET/CART (AIR BUBBLES/LEAK) ISSUE. THE PATIENT ALLEGED HAVING ISSUES WITH AIR BUBBLES WITH ONE PARTICULAR BOX OF CARTRIDGES. TROUBLESHOOTING INDICATED PROPER CARTRIDGE PREPARATION TECHNIQUE. THE PATIENT REPORTED ELEVATED BLOOD GLUCOSE (BG) ASSOCIATED WITH THE AIR BUBBLES, UP TO 379MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264343 ANIMAS INSULIN CARTRIDGE INSULIN PUMP CARTRIDGE LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR