BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN CARTRIDGE

    MDR report key: 2832595 · Received November 14, 2012

    Report

    Report Number
    2531779-2012-13616
    Event Type
    Malfunction
    Date Received
    November 14, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. 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. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION REVEALED THAT THE CARTRIDGE PASSED VISUAL INSPECTION AND THE FILL TEST. A LEAK TEST WAS PERFORMED AND THE CARTRIDGE WAS FOUND TO BE LEAKING FROM THE FIRST O-RING ON THE PLUNGER AND OUT THE VENT HOLE. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER CALLED ON BEHALF OF THE PATIENT TO REPORT ELEVATED BLOOD GLUCOSE READING OF HI, POSSIBLY OVER 600 MG/DL WHILE THERE WAS AIR BUBBLES ISSUE WITH THE INFUSION SET AND THE CARTRIDGE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 AFTER SHE WAS TREATED FOR DKA. ACCORDING TO THE REPORTER, THE PATIENT'S BLOOD GLUCOSE READING CONTINUED TO BE ELEVATED AROUND 304 MG/DL TO 400 MG/DL WHILE SHE WAS ON INSULIN PUMP THERAPY. BY (B)(6) 2012, HER BLOOD GLUCOSE READ "HI, ABOVE 600 MG/DL" AT 9 PM. SHE WAS ABLE TO ADMINISTERED SELF TREATMENT WITH 18 UNITS OF HUMALOG INSULIN VIA SYRINGE THAT NIGHT. ON THE MORNING OF (B)(6) 2012, HER BLOOD GLUCOSE DECREASED TO 89 MG/DL. TROUBLESHOOTING REVEALED THE SUBJECT INSULIN PUMP SYSTEM WAS NOT USED ACCORDING TO THE INSTRUCTION FOR USE (IFU). THE REPORTER HAD BEEN USING REFRIGERATED INSULIN AND RE-USING THE CARTRIDGE. IN ADDITION, THE PRIMING HISTORY SHOWED THE PATIENT WAS NOT PERFORMING A FULL PRIME WITH EACH NEW REPLACEMENT INFUSION SET TUBE BECAUSE THE PATIENT REPORTEDLY DID NOT WANT TO WASTE INSULIN. OTHER USE ERRORS WERE NOTED AS FOLLOW: NOT PRESSURIZING THE INSULIN VIAL AND PATIENT NOT INSPECTING FOR AIR BUBBLES FOR REMOVAL. THIS COMPLAINT IS BEING REPORTED DUE TO USE ERROR AND BECAUSE THE PATIENT HAD ELEVATED BLOOD GLUCOSE ABOVE 500 MG/DL WHILE ON INSULIN PUMP THERAPY.

    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 B201846

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| L| R