BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2067084 · Received April 11, 2011

    Report

    Report Number
    2531779-2011-02531
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Removal / Correction Number
    2531779-02/25/11-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE WAS NOT RETURNED TO ANIMAS. ALTHOUGH THE CARTRIDGE WAS NOT RETURNED THERE IS NO FURTHER INVESTIGATION NECESSARY WITH RESPECT TO THE LEAK ISSUE. CARTRIDGES WITH LOT# B201581 WERE CONFIRMED TO BE DEFECTIVE. WHEN TESTED, FLUID WAS OBSERVED LEAKING FROM THE PLUNGER END OF THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT CONTACTED ANIMAS ALLEGING THAT SHE HAD CARTRIDGES THAT MIGHT HAVE LEAKED. DUE TO THE ALLEGED ISSUE, THE PT CLAIMED THAT HER BLOOD GLUCOSE (BG) LEVELS REACHED AS HIGH AS "600 MG/DL" WITH POSITIVE KETONES. THE PT DENIED EVER NOTICING LEAKING. SHE ALSO DENIED SEEKING MEDICAL INTERVENTION BECAUSE OF THE ALLEGED ISSUE. THE PT REPORTEDLY TREATED HERSELF AT HOME. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT CLAIMED THAT SHE DEVELOPED A BG LEVEL AND SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA BECAUSE OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORPORATION IR 1200 / 1250 / 2020/ OTP B201581

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R