BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2446292 · Received February 10, 2012

    Report

    Report Number
    2531779-2012-01082
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Report Date
    January 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/16/2012-DEVICE EVALUATION: TWO CARTRIDGES FROM LOT # B201701 HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/16/2012 WITH THE FOLLOWING FINDINGS: A VISUAL INSPECTION OF THE CARTRIDGES WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST AND A FILL TEST WERE PERFORMED ON BOTH CARTRIDGES 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

    THE REPORTER STATED THAT AIR BUBBLES WERE DEVELOPING IN THE CARTRIDGES. THE REPORTER CONFIRMED THAT INSULIN WAS ALLOWED TO SIT OUT FOR TWO HOURS PRIOR TO FILLING THE CARTRIDGE, THE CARTRIDGE WAS FILLED SLOWLY WITHOUT OVER PRESSURIZING THE INSULIN VIAL, AND THE CARTRIDGE WAS LEFT OUT TO DEBUBBLE BEFORE USE. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE INSULIN CARTRIDGE DEVELOPED AIR BUBBLES.

    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 9 YR