BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2841386 · Received November 21, 2012

    Report

    Report Number
    2531779-2012-13823
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K032257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE HAS NOT BEEN RETURNED TO ANIMAS. 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 REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) AND THAT THE PATIENT WAS TAKEN TO THE ER WITH A BG READING OF "HI" (>600MG/DL) AND VOMITING. THE PATIENT WAS REPORTEDLY TREATED FOR TWO HOURS WITH IV FLUIDS AND IV INSULIN IN THE ER AND THEN WAS MOVED TO A REGULAR FLOOR. THE PATIENT WAS REPORTEDLY DISCONNECTED FROM THE PUMP AND WAS ON INSULIN INJECTIONS AT THE TIME OF THE CALL TO ANIMAS CUSTOMER SUPPORT. TROUBLESHOOTING INDICATED THAT THE CANNULA WAS BENT AT THE TIME OF THE "HI" BG READING. THE REPORTER NOTED THAT THE SITE/SET HAD BEEN CHANGED ON (B)(6) 2012, AND THAT THE PATIENT'S BGS HAD BEEN ELEVATED SINCE THE SITE/SET CHANGE. DURING TROUBLESHOOTING, THE REPORTER ALSO NOTED THAT THE CARTRIDGE AND TUBING HAD NOT BEEN CHANGED AND UPON REVIEW, AIR BUBBLES WERE PRESENT IN THE TUBING AND THE CARTRIDGE. THE REPORTER STATED THAT REFRIGERATED INSULIN IS USED WHEN FILLING CARTRIDGES. TROUBLESHOOTING INDICATED INSERTION AND CARTRIDGE FILL TECHNIQUE ISSUES. CUSTOMER SUPPORT REVIEWED PROPER INSERTION AND CARTRIDGE FILL TECHNIQUE WITH THE REPORTER AND ALSO RECOMMENDED THAT INSULIN BE ALLOWED TO COME TO ROOM TEMPERATURE PRIOR TO FILLING CARTRIDGES. ANIMAS DOES NOT MANUFACTURE THE INFUSION SET BUT WILL FORWARD THE COMPLAINT TO THE RELEVANT MANUFACTURER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION AND AIR BUBBLES IN THE CARTRIDGE RELATED TO USE ERROR CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE ALLEGED INCIDENT.

    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 11 YR Hospitalization| L| R