BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2211170 · Received August 15, 2011

    Report

    Report Number
    2531779-2011-05867
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED OCCLUSION AND CALL SERVICE ALARMS ARE NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. 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 PATIENT REPORTED THAT HE EXPERIENCED BLOOD GLUCOSE (BG) OF 500 MG/DL, AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL ON (B)(6) 2010 WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). THE PATIENT STATED THAT MULTIPLE OCCLUSION AND CALL SERVICE ALARMS OCCURRED WHILE ATTEMPTING TO PRIME AND ALSO WHILE ATTEMPTING TO BOLUS. THE PATIENT STATED THAT HE LAST ORDERED CARTRIDGES IN 2008, AND HAD BEEN RE-USING THE CARTRIDGES. HE WAS UNSURE IF THE CARTRIDGES WERE EXPIRED. THE USER GUIDE INSTRUCTS THE USER NOT TO USE CARTRIDGES FOR MORE THAN THREE DAYS, AND NOT TO USE EXPIRED CARTRIDGES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY. CUSTOMER SUPPORT CONCLUDED THAT USE ERROR WAS A CAUSE OR CONTRIBUTOR TO THE PATIENT'S REPORTED HYPERGLYCEMIC EVENT.

    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 56 YR Hospitalization