BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2191651 · Received August 4, 2011

    Report

    Report Number
    2531779-2011-05607
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG #: 100-124-01. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: NO PRODUCT WAS RETURNED; A RETAINED SAMPLE FROM THE SAME LOT WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSES VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE OBSERVED TO THE LUER CONNECTION, O-RINGS, PLUNGER, OR CARTRIDGE BODY. A FILL TEST WAS COMPLETED WITH NO AIR BUBBLES BEING FORMED INSIDE THE CARTRIDGE. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS OR ANYWHERE ELSE IN THE CARTRIDGE. A FORCE TEST WAS PERFORMED WITH NO FAILURES.

    Description of Event or Problem · 1

    THE PATIENT REPORTED AIR BUBBLES OCCURRING IN FIVE CARTRIDGES FROM THE SAME LOT OVER THE PAST THREE MONTHS. SHE STATED THAT SOMETIMES SHE FILLS THE CARTRIDGE WITH REFRIGERATED INSULIN, AND SOMETIMES SHE LETS THE INSULIN SIT AT ROOM TEMPERATURE FOR 30 MINUTES PRIOR TO FILLING THE CARTRIDGE. THE PATIENT STATED THAT SHE IS ABLE TO CLEAR THE BUBBLES BY DISCONNECTING FROM THE TUBING AND PRIMING OUT THE BUBBLES. CUSTOMER SUPPORT ADVISED THE PATIENT TO FILL CARTRIDGES WITH ROOM TEMPERATURE INSULIN INSTEAD OF REFRIGERATED INSULIN TO PREVENT AIR BUBBLES.

    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 B201628

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR