BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2328204 · Received November 8, 2011

    Report

    Report Number
    2531779-2011-08359
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Report Date
    October 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARTRIDGE LOT # B201671. THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS SHALL CONDUCT A LOT PROFILE TEST ON THE CARTRIDGE LOT AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: NO CARTRIDGE WAS RETURNED; A RETAINED SAMPLE WAS EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE CARTRIDGE PASSED VISUAL INSPECTION, NO DAMAGE OR DEFECTS WERE NOTED TO THE LUER CONNECTION OR O-RINGS. 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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER BLOOD GLUCOSE LEVEL WAS 400 MG/DL ON OCTOBER 15. THE READING DOES NOT FIT ANIMAS CRITERIA OF A SERIOUS DIABETIC INJURY. WHEN SHE REMOVED THE CARTRIDGE AND TUBING TO CHANGE THEM SHE PUSHED ON THE PLUNGER MANUALLY AND STATES INSULIN LEAKED OUT OF THE BODY OF THE CARTRIDGE AND INTO HER HAND. SHE IS UNSURE WHETHER THE PLUNGER WAS COCKED AT THE TIME OF PUSHING. SHE DENIES ANY LEAKAGE FOUND IN THE CARTRIDGE COMPARTMENT. SHE DISCARDED THE CARTRIDGE BUT IS CONCERNED AS TO WHY IT WOULD LEAK WHEN SHE PUSHES THE PLUNGER. THE ANIMAS REPRESENTATIVE INSTRUCTED THE PATIENT TO CYCLE THE CARTRIDGE ONLY TWICE VERY SLOWLY. THE PATIENT REPORTEDLY CYCLES THE CARTRIDGE FOUR TIMES BEFORE FILLING IT WITH INSULIN.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR