BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHECK RAPID D

    MDR report key: 2066056 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-00993
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 15, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, CERTIFIED DIABETES EDUCATOR REPORTED THAT PT EXPERIENCED PAIN AT HER INFUSION SITE AND HYPERGLYCEMIA WHEN USING THE INFUSION SETS. PT RECEIVED TRAINING AND STARTED INFUSION DEVICE THERAPY ON (B)(6) 2011. NORMAL BLOOD GLUCOSE RANGE IS 100-150 MG/DL, AND BLOOD GLUCOSE ELEVATED TO THE 300 MG/DL RANGE. PT REPORTED THE INFUSION SITE SEEMED INFECTED, WAS "SERIOUSLY PAINFUL", AND HAD PUS DRAINING FROM IT. F/U WAS ATTEMPTED ON (B)(6) 2011 AND WAS UNSUCCESSFUL. PT THEN CALLED ON (B)(6) 2011 TO PROVIDE ADD'L DETAILS. INFUSION NEEDLE IS USED FOR 2 DAYS, AND IT BECOMES PAINFUL ON THE SECOND DAY OF USE. BLOOD AND PUS DRAIN FROM THE INFUSION SITE AFTER THE NEEDLE IS REMOVED. THIS HAS OCCURRED WITH 3 DIFFERENT INFUSION SETS AND WITH 3 DIFFERENT INFUSION SITES. PT WAS PRESCRIBED AN ANTIBIOTIC BY HER HEALTH CARE PROVIDER TO TREAT THE INFECTION. INFUSION SITE IS CLEANSED WITH ALCOHOL WIPE PRIOR TO INSERTION. THERE IS NO SCAR TISSUE, HAIR, OR BRUISING AT THE INFUSION SITES. PRODUCT WAS REPLACED WITH A DIFFERENT TYPE OF INFUSION SET. ALLEGED INFUSION SETS WERE NOT AVAILABLE TO RETURN FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK RAPID D INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 32332110

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention INSULIN INFUSION DEVICE| INSULIN