BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 3061789 · Received April 16, 2013

    Report

    Report Number
    2183996-2013-00677
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 9, 2013
    Report Date
    June 26, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIBING A SKIN INFECTION CANNOT BE VERIFIED, THE HEADSET MEETS PRODUCT SPECIFICATIONS. UNOMEDICAL HAS PERFORMED AN INVESTIGATION IN ATTEMPT TO IDENTIFY ANY MALFUNCTIONS RELATED TO SKIN INFECTION. A VISUAL INSPECTION AND TESTS FOR NEEDLE WERE PERFORMED ON THE RETURNED UNUSED SAMPLES (10). ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR NEEDLE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. STERILIZATION FOR LOT 5011432 WAS VERIFIED AND FOUND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT REPORTED HE HAS EXPERIENCED A FEVER AND INFECTION ON HIS ABDOMEN WHILE USING 2 LOTS OF INFUSION SETS OVER THE PAST MONTH. HE ROTATED HIS INFUSION SITES BUT CONTINUED TO EXPERIENCE THE CONCERN. HIS PHYSICIAN PRESCRIBED ANTIBIOTICS AND A CREAM TO TREAT THE INFECTION. THE INFUSION SETS WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164082 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. 00700006959 5011432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention