BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 1971392 · Received January 12, 2011

    Report

    Report Number
    2531779-2011-00187
    Event Type
    Injury
    Date Received
    January 12, 2011
    Report Date
    December 15, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVAL HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT'S MOM CLAIMED THERE HAS BEEN BUBBLE FORMATION IN ALL 6 CARTRIDGES THAT CAME FROM THE SAME BOX AND THAT THE PT'S BLOOD GLUCOSE HAS BEEN IN THE 20'S MMOL/L: IT WAS NOT SPECIFIED IF THE PATIENT'S BLOOD GLUCOSE EVER WENT OVER 500 MG/DL. IT WAS NOT REPORTED IF THE PATIENT WAS SYMPTOMATIC OR HAD TO RECEIVE MEDICAL ATTENTION AS A RESULT OF THE REPORTED ISSUE. SHE INDICATED THAT THE CARTRIDGE AND INSULIN WERE AT ROOM TEMPERATURE AND THE BUBBLES ARE REMOVED FROM THE CARTRIDGE BEFORE BEING INSERTED INTO THE PUMP. THE BOX OF CARTRIDGE WAS REPLACED. BASED ON THE PROVIDED INFO, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S BLOOD GLUCOSE WAS IN THE 20'S MMOL/L AS A RESULT OF THE REPORTED AIR BUBBLE ISSUE WITH THE CARTRIDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN CARTRIDGE INSULIN CARTRIDGE LZG ANIMAS CORP. IR1200/1250/2020/OTP B201482

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening