BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2056059 · Received April 1, 2011

    Report

    Report Number
    2531779-2011-01945
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. THERE IS NO INVESTIGATION NECESSARY. CARTRIDGES WITH THE REPORTED LOT # WERE CONFIRMED TO BE DEFECTIVE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER ALLEGED THAT THE PT'S INSULIN CARTRIDGE WITH LOT# B201581 WAS LEAKING. THE PT'S BLOOD GLUCOSE NORMALLY READS BETWEEN 100-200 MG/DL WHEN THERE IS NO ISSUE. HOWEVER, THE REPORTER INDICATED THAT THE PT BLOOD GLUCOSE FOR THE LAST FEW WEEKS HAVE BEEN IN THE RANGE OF 300-400 MG/DL WITH SYMPTOMS DESCRIBED AS "NAUSEA AND KETONES (UNDISCLOSED AMOUNT)". REPORTEDLY, THE PT'S BLOOD GLUCOSE CAME DOWN TO NORMAL WHEN THERE WAS A CORRECTION WITH THE PUMP AND SYRINGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PT HAD SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA WHILE USING THE EFFECTED LOT# B201581.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR1200/1250/2020/OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening| R