BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDIPLAST

    MDR report key: 6251740 · Received January 13, 2017

    Report

    Report Number
    9614769-2017-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2017
    Date of Event
    June 13, 2016
    Report Date
    August 9, 2016
    Manufacturer
    LP ITALIANA
    Product Code
    JPH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE PROBLEM WAS REPORTED TO POLYMEDCO, POLYMEDCO PERFORMED TESTING ON RETAIN MATERIAL FOR THE LOT U0738B, USING A GLYCEROL SOLUTION TO MIMIC CONSISTENCY OF WHOLE BLOOD. NONE OF THE TUBES THAT WERE TESTED WERE FOUND DEFECTIVE AND ALL PERFORMED ACCEPTABLY. THE ACTUAL KIT THAT WAS USED BY THE LABORATORY TECHNICIAN WAS FINALLY RETURNED TO POLYMEDCO ON 08/08/2016 AND TESTED. THE 59 TESTS REMAINING IN THE KIT OF 100 TESTS WERE TESTED WITH ERYTHROCYTE CONTROLS AND WITH THE GLYCEROL SOLUTION. ONE OF THE 59 TUBES DEMONSTRATED LEAKAGE OF THE CONTENTS FROM THE TOP OF THE TUBE. RECORDS OF INCOMING QUALITY CONTROL TESTING FOR THE LOT WERE REVIEWED. THE LOT PASSED INCOMING QC TESTING, WHICH INVOLVES TESTING OF A SAMPLE FROM THE LOT WITH THE GLYCEROL SOLUTION. NO PHYSICAL DEFECTS WERE IDENTIFIED IN THE INSPECTION SAMPLE. RESUBMITTING MDR 1/13/2017 DUE TO UPLOAD ERRORS. MDR ORIGINALLY UPLOADED 11/16/2016.

    Description of Event or Problem · 1

    WHEN USING SEDIPLAST S-1000 LOT U0738B ON PATIENT BLOOD, THE SAMPLE ESCAPED FROM THE TOP OF TUBE AND EXPOSED THE LABORATORY TECHNICIAN TO THE PATIENT BLOOD, THE CUSTOMER REPORTED THAT THE TECHNICIAN WAS TESTED FOR (B)(6) WITH NEGATIVE RESULTS. FROM THE REPORT SUBMITTED BY THE USER: "WHILE SETTING UP A ESR I WAS SPLASHED IN THE EYE WITH A PATIENTS BLOOD. THIS WAS DUE TO A FAILURE OF THE ESR TUBE TOP AS IT ALLOWED THE BLOOD TO ESCAPE THE TOP OF THE MEASURING COLUMN. THE LOT NUMBER OF THE DEVICE IS U0738B. THE MANUFACTURER IS POLYMED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34524 SEDIPLAST ERYTHROCYTE SEDIMENTATION RATE MANUAL TEST; PRODUCT CODE JPH JPH LP ITALIANA U0738B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other