BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2882125 · Received December 20, 2012

    Report

    Report Number
    2531779-2012-14931
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP 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

    FOLLOW-UP #1 DATE OF SUBMISSION 03/11/2013-DEVICE EVALUATION: THE CARTRIDGE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 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. A RETAIN CARTRIDGE FROM THE SAME LOT WAS ALSO TESTED, 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) 2012, THE REPORTER CONTACTED ANIMAS PATIENT REPORTS SHE WAS HAVING HIGH BLOOD GLUCOSE LEVELS (BG) OF AROUND 295 MG/DL WITH A MILD HEADACHE LAST NIGHT AND SHE WENT TO CHANGE OUT SITE/SET/CART SHE SMELLED INSULIN IN THE CARTRIDGE COMPARTMENT. PATIENT IS POOR HISTORIAN AND WAS NOT SURE IF INSULIN WAS LEAKING AT LUER CONNECTION OR AT BOTTOM OF CARTRIDGE. PATIENT CHANGED OUT SITE/SET/CART AND GAVE CORRECTION BOLUS TO LOWER BG. PATIENT HAS HEART CONDITIONS AND TAKES BETA BLOCKERS. PATIENT ALSO REPORTS SHE HAS BEEN TOLD SHE HAS POOR ABSORPTION OF INSULIN. PATIENT REPORTS SMELLED INSULIN IN CARTRIDGE COMPARTMENT ABOUT 2 WEEKS AGO TOO DURING CARTRIDGE CHANGE, PATIENT DISCARDED THAT CARTRIDGE AND WAS NOT SURE WHERE IT WAS LEAKING AT CARTRIDGE. PATIENT IS POOR HISTORIAN AND WAS NOT SURE IF INSULIN WAS LEAKING AT LUER CONNECTION OR AT BOTTOM OF CARTRIDGE. ADVISED PATIENT TO CONTACT CUSTOMER SUPPORT AS SOON AS SHE NOTICES LEAKING IN CARTRIDGE COMPARTMENT TO TROUBLESHOOT ISSUE. THIS ISSUE IS BEING REPORTED DUE TO THE ALLEGATION THAT THE CARTRIDGE IS LEAKING INSULIN. THE BLOOD GLUCOSE EXCURSION DOES NOT MEET THE CRITERIA OF AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART B201822

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR