BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTHER

    MDR report key: 2071108 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02931
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED TO ANIMAS AS THERE WAS NO EVIDENCE OF A MALFUNCTION. THE REPORT IS UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED HIGH BLOOD GLUCOSE WITH THE PRESENCE OF LARGE KETONES WHILE HAVING ISSUE WITH THE MULTIPLE BUBBLES IN THE ANIMAS CARTRIDGE. THE NIGHT PRIOR TO CONTACTING ANIMAS, THE PATIENT HAD A HIGH BLOOD GLUCOSE READING AT 1 AM AND WAS GIVEN A CORRECTION BOLUS. THE PATIENT REPORTEDLY WOKE UP WITH A FASTING BLOOD GLUCOSE READING OF "480 MG/DL" AT 7 AM WITH DETECTIONS OF LARGE KETONES. THERE WAS NO SYMPTOM AT THE TIME OF CONCERN. THE PATIENT WAS GIVEN ANOTHER CORRECTION BOLUS BUT THE PATIENT'S BLOOD GLUCOSE REMAINED IN THE 400 MG/DL. THE REPORTER CLAIMED SHE CHANGED THE CARTRIDGE AND SITE/SET AND DISCOVERED MULTIPLE AIR BUBBLES IN THE CARTRIDGE. AFTER THE NEW CARTRIDGE WAS UTILIZED TO BOLUS, THE PATIENT'S BLOOD GLUCOSE LOWERED TO 200 MG/DL. DURING TROUBLESHOOTING, THE ANIMAS HEALTHCARE REPRESENTATIVE WALKED THE CUSTOMER THROUGH THE CORRECT TECHNIQUE AND MADE SURE THE PATIENT WAS UTILIZED THE INSULIN AT ROOM TEMPERATURE. THE INSULIN WAS NOT EXPIRED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE AIR BUBBLES IN THE CARTRIDGE ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTHER INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 6 Life Threatening| R