BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDERLINK INFUSION SET

    MDR report key: 2959008 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00202
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    December 1, 2012
    Report Date
    May 31, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED PRODUCT MEETS THE SPECIFICATIONS. RESULT A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED USED DEVICE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE NEEDLE TEST CANNOT BE PERFORMED DUE TO THE INTRODUCER NEEDLE WAS NOT RETURNED. A VISUAL INSPECTION AND TESTS FOR NEEDLE WERE PERFORMED ON THE RETURNED UNUSED DEVICE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR NEEDLE. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. STERILIZATION BATCH FOR LOT # 0230067 WAS VERIFIED AND FOUND IT WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE OF 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.

    Description of Event or Problem · 1

    PATIENT REPORTED AFTER USING THE INFUSION SET FOR 2 DAYS, AN ABSCESS FORMED. PATIENT STATED THIS OCCURRED TWICE IN 2012. PATIENT DOESN'T RECALL THE DATE OR THE TIME. PATIENT REPORTED THE ABSCESS WAS TREATED WITH SURGICAL THERAPY AND ANTIBIOTIC THERAPY. PATIENT STATED NO STATIONARY TREATMENT WAS NEEDED. PATIENT REPORTED DISINFECTING THE INFUSION SET WITH CUTASEPT. PATIENT USES CAVILON SPRAY. PATIENT STATED IN (B)(6) 2012 THE (B)(4) WASN'T GOOD; NO VALUE WAS PROVIDED. NO FURTHER INFORMATION IS AVAILABLE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53614 ACCU-CHEK TENDERLINK INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC. 00700006951 0230067

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES