BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2792642 · Received October 16, 2012

    Report

    Report Number
    2531779-2012-12335
    Event Type
    Injury
    Date Received
    October 16, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT A HIGH BLOOD GLUCOSE (BG) EXCURSION. THE PATIENT REPORTED A BG IN THE 500'S MG/DL AFTER HAVING REPLACED THE INFUSION SET THE DAY PRIOR. CUSTOMER SUPPORT NOTED THAT THE PATIENT SOUNDED "OUT OF BREATH" AND DURING THE CALL THE PATIENT VOMITED AND WHEN SHE RECHECKED HER BG HER METER READ "HIGH" (BG >600MG/DL). DURING A FOLLOW-UP CALL ON (B)(6) 2012, THE PATIENT'S HUSBAND REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE HER ADMITTING BG WAS OVER 600MG/DL AND WAS PLACED ON INSULIN DRIP. THE PATIENT'S SPOUSE STATED INSULIN PUMP THERAPY WAS RESUMED THAT DAY. DURING INITIAL CALL TO CUSTOMER SUPPORT, PRIOR TO PATIENT'S HOSPITALIZATION, THE PATIENT REMOVED INFUSION SET AND DENIED ANY ISSUES WITH CANNULA OR AT SITE. THE PATIENT'S SPOUSE REPORTED SEEING AN AIR BUBBLE IN THE CARTRIDGE. DURING FOLLOW-UP CALL ON (B)(6) 2012, THE PATIENT'S HUSBAND REPORTED THAT THE HIGH BG WAS DUE TO USE ERROR. THE PATIENT'S SPOUSE STATED THAT THEY HAD DISCOVERED THAT THE PATIENT HAD NOT TIGHTENED THE TUBING CORRECTLY TO THE CARTRIDGE. THE PATIENT'S SPOUSE DISCOVERED A PUDDLE OF INSULIN ON OR NEXT TO PATIENT'S BED. THE PATIENT'S SPOUSE INFORMED CUSTOMER SUPPORT THAT THE ISSUE WAS RESOLVED. THE PATIENT WAS TAKEN OFF THE INSULIN DRIP ON (B)(6) 2012 AND PLACED BACK ON THE PUMP. AT TIME SHE WAS TAKEN OFF OF INSULIN DRIP HER BGS WERE IN THE 400'S MG/DL. AFTER RESUMING PUMP THERAPY, IT WAS REPORTED THAT THE PATIENT'S BG BEGAN TO DROP INTO THE 300'S MG/DL RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS TREATED FOR HYPERGLYCEMIA BY AN HCP WHILE ON INSULIN PUMP THERAPY. THE PATIENT'S ALLEGED HYPERGLYCEMIA CAN BE ATTRIBUTED TO USE ERROR, AS IT WAS DISCOVERED THAT THE PATIENT DID NOT CONNECT THE INFUSION SET TUBING PROPERLY TO THE CARTRIDGE CAUSING AIR BUBBLE IN CARTRIDGE AND ALSO RESULTING IN INSULIN LEAKING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R