BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2042209 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02004
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANIMAS CORP.
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE RPTR CLAIMED THAT SHE HAS THE RECALL CARTRIDGE WITH LOT # B201576. THE PT'S BLOOD GLUCOSE REPORTEDLY WAS ERRATIC WITH READINGS AS HIGH AS "279 MG/DL" WITH SYMPTOM OF THIRST AND AS LOW AS "54 MG/DL" DURING THE ALLEGED EVENT. THE PT HAD 4 BOXES ALTOGETHER. REPORTEDLY, THERE WAS NO VISIBLE LINKAGE BUT THE SMELL OF INSULIN WAS NOTED. THE PT ADMINISTERED SELF-TREATMENT ACCORDINGLY WAS ABLE TO STABILIZE THE BLOOD GLUCOSE BETWEEN 92 AND 106 MG/DL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT REPORTEDLY HAD ACUTE COMPLICATION OF DIABETES WHILE USING THE RECALL LOT # B201576.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN INFUSION PUMP CARTRIDGE LZG ANIMAS CORP. IR 1200/1250/2020/OTP B201576

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| R