BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK RAPID D

    MDR report key: 2232494 · Received August 25, 2011

    Report

    Report Number
    2183996-2011-02335
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED THAT SHE WAS HOSPITALIZED WITH HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS DUE TO INSULIN NOT BEING DELIVERED CORRECTLY THROUGH THE INFUSION SETS. PT USES A COMPETITOR¿S INFUSION DEVICE AND EXPERIENCED SEVERAL OCCLUSIONS 3 DAYS BEFORE SHE WAS HOSPITALIZED. SHE CONTACTED THE MFR OF THE INFUSION DEVICE TO COMPLETE TROUBLESHOOTING. PT CHANGED THE INFUSION TUBING 3 TIMES ON (B)(6) 2011. THE ERROR MESSAGES CLEARED ON THE INFUSION DEVICE, AND PT ASSUMED INSULIN WAS BEING DELIVERED. PT WAS ADMITTED TO THE HOSP ON (B)(6) 2011 AND DISCHARGED ON (B)(6) 2011. BLOOD GLUCOSE ELEVATED TO THE HIGH-300 MG/DL RANGE PRIOR TO HOSPITALIZATION. PT INCREASED HER BASAL RATE TO 200% AND DELIVERED CORRECTION BOLUSES THROUGH THE INFUSION DEVICE. BLOOD GLUCOSE WAS 300 MG/DL WHEN SHE WAS ADMITTED. PT WAS TREATED WITH AN INSULIN DRIP, AND BLOOD GLUCOSE DECREASED AFTER APPROXIMATELY 24 HRS. TARGET BLOOD GLUCOSE IS 110 MG/DL. PT REPORTED THE HOSP TESTED THE INFUSION TUBING BY COMPLETING A PRIME, AND NO INSULIN DRIPPED FROM THE TUBING. PT REPORTED THE TUBING DOES NOT FEEL NORMAL AND IS ¿BUMPY.¿ INFUSION SETS WERE REPLACED WITH A DIFFERENT TYPE AND REQUESTED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC NA 32402250

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R (DATE OF TX (B)(6))| INSULIN (DATE OF TX (B)(6))| INSULIN INFUSION DEVICE