BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2069395 · Received March 28, 2011

    Report

    Report Number
    2531779-2011-02001
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE CARTRIDGE WITH LOT # B201576 WAS PART OF THE RECALL. THE PT'S BLOOD GLUCOSE REPORTEDLY TESTED IN THE RANGE OF "300 MG/DL" DURING THE ALLEGED EVENT. THERE WAS NO MEDICAL INTERVENTION OR SYMPTOMS THAT WOULD SUGGEST A SERIOUS INJURY. HENCE, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION.

    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 13 YR