BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2802192 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12667
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    September 29, 2012
    Report Date
    September 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGES HAVE NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION. THIS REPORT IS MADE 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 CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH THE DIAGNOSIS OF DIABETIC KETOACIDOSIS ON (B)(6) 2012 AT APPROXIMATELY 9:00 PM. THE PATIENT WAS REPORTED TO HAVE HAD ELEVATED BLOOD GLUCOSE (BG) OF 546 MG/DL WITH KETONES, NAUSEA, VOMITING AND ABDOMINAL CRAMPS. DURING HOSPITALIZATION THE PATIENT WAS DISCONTINUED FROM INSULIN PUMP THERAPY AND WAS BEGUN ON AN IV INSULIN DRIP. THE REPORTER STATED THAT WHEN THE PATIENT'S INFUSION SET WAS REMOVED, THERE WERE NO ISSUES WITH THE SET, CANNULA, OR SITE. THE PATIENT WAS REPORTEDLY DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 AT APPROXIMATELY 4:00AM ON A BACKUP PLAN WITH LANTUS AND NOVOLOG UNTIL WHICH TIME THE PUMP COULD UNDERGO TROUBLESHOOTING. THE PATIENT'S BG AT THE TIME OF THE CALL TO ANIMAS WAS 146 MG/DL. THE REPORTER STATED THE PUMP HAD BEEN EMITTING MULTIPLE OCCLUSION ALARMS SINCE (B)(6) 2012. THE REPORTER STATED THAT THE PUMP WAS ABLE TO BE PRIMED EACH OF THESE TIMES. REVIEW OF THE PRIME HISTORY INDICATED THE SITE/SET WAS NOT BEING CHANGED EVERY 2-3 DAYS. THE PATIENT HAD CHANGED THE SITE SEVERAL TIMES DUE TO THE OCCLUSIONS, BUT WAS NOT CHANGING THE CARTRIDGE BUT EVERY 4-6 DAYS. THE REPORTER CONFIRMED THE SITE HAD BEEN CHANGED OUT 4 TIMES USING EXPIRED SUPPLIES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG RESULTING IN HOSPITALIZATION WHILE ON INSULIN PUMP THERAPY USING EXPIRED SUPPLIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR