BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2499540 · Received March 22, 2012

    Report

    Report Number
    2531779-2012-02335
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION = PATIENT CALLED ANIMAS BACK ON (B)(6) 2012 AND PROVIDED THE CARTRIDGE LOT # FOR THE ALLEGED COMPLAINT. LOT # IS B201740.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE CARTRIDGE WAS NOT RETURNED FOR INVESTIGATION. A RETAIN SAMPLE CARTRIDGE FROM LOT # B201740 HAS BEEN EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 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.

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT CONTACTED ANIMAS ALLEGING THAT SHE HAS HAD AIR BUBBLES IN THE CARTRIDGE FOR THE PAST FEW WEEKS. WHILE ON THE PHONE WITH ANIMAS CUSTOMER SUPPORT, THE PATIENT WAS ABLE TO PRIME OUT THE AIR BUBBLES THROUGH THE INFUSION SET TUBING. THERE WERE NO REPORTED BLOOD GLUCOSE EXCURSIONS AS A RESULT OF THE ALLEGED MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED AIR BUBBLE ISSUE WAS RECURRING AND BECAUSE AIR BUBBLES IN THE SYSTEM MAY AFFECT INSULIN DELIVERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR