BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 1941908 · Received December 23, 2010

    Report

    Report Number
    2531779-2010-03091
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. A SAMPLE CARTRIDGE WITH THE SAME LOT NUMBER FROM THE PT'S ORDER HISTORY WAS TESTED. EVAL REVEALED NO VISIBLE CARTRIDGE DAMAGE. THERE WERE NO AIR BUBBLES DUPLICATED UPON A FILL TEST AND THERE WERE NO LEAKS OBSERVED WHEN PERFORMING A LEAK TEST. THE ANIMAS REP NOTED THAT THE PT'S TECHNIQUE WHEN FILLING THE CARTRIDGE MAY HAVE CAUSED AIR BUBBLES IN THE CARTRIDGE. THE ANIMAS REP ADVISED THE REPORTER TO MAKE SURE THE CARTRIDGE CONNECTION TO THE LUER WAS TIGHT. THERE WERE NO LEAKS OBSERVED WHEN THE REP TROUBLESHOT WITH THE REPORTER.

    Description of Event or Problem · 1

    THE PT'S MOTHER REPORTED THAT HER DAUGHTER WENT TO THE EMERGENCY ROOM WITH A BLOOD GLUCOSE LEVEL OF OVER 600 MG/DL AND LARGE KETONES AND NAUSEA. WHEN THE PT ARRIVED AT THE HOSPITAL, SHE NOTICED AIR BUBBLES IN THE INFUSION SET TUBING AND THE CARTRIDGE. SHE ALSO NOTICED THAT INSULIN WAS LEAKING FROM THE LUER CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP. IR 1200 / 1250/ 2020/ OTP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L| R