BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 2171096 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01976
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HAVING PAIN AT THE INFUSION SITE ON THE 3RD DAY OF USING THE INFUSION SET. PT STATED, SHE NOTICED A LUMP UNDERNEATH THE SKIN AFTER REMOVING THE INFUSION HEADSET. PT REPORTED NO INSULIN LEAKAGE. PT REPORTED NO BRUISING AT THE INFUSION SITE LOCATION PRIOR TO INSERTION. ON CALL BACK ON (B)(6) 2011, PT REPORTED SHE HAD TO GO TO THE EMERGENCY ROOM DUE TO THE INFUSION SET. PT STATED, SHE WAS GIVEN A TOPICAL CREAM AND ORAL ANTIBIOTIC TO TREAT THE INFECTION AND ABSCESS CAUSED BY THE INFUSION SET. PT REPORTED THAT 2 OF THE 3 INFUSION SITES USED WITH THE INFUSION SET GOT AN INFECTION AND THE 3RD INFUSION SITE HAS AN ABSCESS. PT STATED, SHE WAS TREATED AND RELEASED FROM THE EMERGENCY ROOM AND NOT ADMITTED TO THE HOSPITAL. PT REPORTED, SHE WILL BE SEEING THE DOCTOR AGAIN THIS WEEK FOR A CHECKUP ON THE INFECTED SITES. PT DISCARDED THE ALLEGED INFUSION SETS. REPLACEMENT INFUSION SETS WERE SENT; NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 640526

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R INSULIN INFUSION PUMP| INSULIN