BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® RAPID-D INFUSION SET

    MDR report key: 3123556 · Received May 22, 2013

    Report

    Report Number
    2183996-2013-00905
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    November 4, 2012
    Report Date
    June 11, 2013
    Manufacturer
    FRESENIUS KABI DEUTSCHLAND GMBH
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. NO PRODUCT AVAILABLE TO BE RETURNED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. LOT/SERIAL NUMBER IS NOT AVAILABLE. THEREFORE NO INVESTIGATION WAS POSSIBLE. NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT HAD INSERTED HER INFUSION SITE AND IMMEDIATELY FELT A STINGING SENSATION. SHE REMOVED THE INFUSION SET AND CHOSE A DIFFERENT INFUSION SITE. HOWEVER, THE STINGING DID NOT GO AWAY FROM THE PREVIOUS SITE OVER THE COURSE OF THE FOLLOWING DAYS. THE SITE BECAME RED AND BRUISED. AFTER A WEEK, THE PATIENT STATED BROWN FLUID WAS COMING FROM THE SITE AND SHE WENT TO SEE HER DOCTOR. ON (B)(6) 2012, HER DOCTOR TOLD HER THAT THE SITE WAS INFECTED AND SHE NEEDED TO GO TO THE HOSPITAL. SHE WENT TO THE HOSPITAL AND SHE WAS GIVEN EMERGENCY SURGERY. SHE WAS IN THE HOSPITAL FOR THREE DAYS. THE PATIENT STATED THAT SHE HAS BEEN AFRAID TO USE HER INFUSION DEVICE SINCE THE INCIDENT. THE PATIENT WAS SENT COMPLIMENTARY INFUSION SETS SO SHE CAN RESUME USE OF THE INFUSION DEVICE. THE PATIENT DISCARDED THE USED INFUSION SET. NO PRODUCT WILL BE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225841 ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET FPA FRESENIUS KABI DEUTSCHLAND GMBH NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR Hospitalization| R SOMA| NORCO| APIDRA INSULIN