BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® TENDER INFUSION SET

    MDR report key: 3790882 · Received May 5, 2014

    Report

    Report Number
    1823260-2014-03202
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    August 8, 2013
    Report Date
    May 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. PRODUCT DISCARDED BY PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT REPORTED THAT HE HAD AN ALLERGIC REACTION ABOUT 8 MONTHS AGO TO HIS INFUSION SET. HE STATED HE HAD A SKIN IRRITATION ON HIS UPPER ABDOMEN AND IT DEVELOPED INTO AN INFECTION. HE WAS GIVEN UNKNOWN ANTIBIOTICS. IT DEVELOPED INTO AN ABCESS THAT HE HAD TO HAVE SURGICALLY REMOVED. THE INFUSION SET WAS DISCARDED AND HE HAS NO OTHER INFUSION SETS FROM THAT BOX;THEREFORE, NO PRODUCT COULD BE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266460 ACCU-CHEK ® TENDER INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 066 YR Required Intervention