BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIANT II HEMOGLOBIN TESTING SYS

    MDR report key: 4265586 · Received November 18, 2014

    Report

    Report Number
    2915274-2014-00054
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 27, 2014
    Report Date
    November 18, 2014
    Manufacturer
    BIO-RAD LABORATORIES INC
    Product Code
    LCP
    PMA / PMN Number
    K130860
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR; HOWEVER, A FIELD SERVICE ENGINEER (FSE) DID EVALUATE THE DEVICE ON-SITE AND CONCLUDED THAT THE INSTRUMENT WAS PLUGGED/RESTRICTED. THE FSE DID RESOLVE THIS ISSUE. USING INTERNAL RESOURCES, A ROOT-CAUSE HAS BEEN IDENTIFIED AS RESTRICTION/WASTE BUILDUP IN EXTERNAL WASTE TUBING, WHICH CAN CAUSE A FLUID OVERFLOW. THE REMOVAL OF PLASTIC SAFETY COVER IN FRONT OF THE DILUTION WELL, WHILE THE INSTRUMENT IS IN USE, EXPOSES THE OPERATOR TO THE OVERFLOWED FLUID. INSTRUCTIONS FOR USE CLEARLY ADVISE THE OPERATOR TO USE APPROPRIATE PPE. WE ARE CURRENTLY EVALUATING SOLUTIONS TO PREVENT OVERFLOW.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS BEING CONDUCTED ON WHETHER THE INSTRUMENT MALFUNCTIONED. THERE WERE NO PT SAMPLES THAT WERE RUN IN BETWEEN THE DECONTAMINATION AND WHOLE BLOOD PRIMER RUN. EACH UNIT OF WHOLE BLOOD USED IN THE MANUFACTURE OF THE WHOLE BLOOD PRIMER ARE TESTED BY FDA ACCEPTED METHODS AND ARE FOUND (B)(6) FOR (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER PERSONNEL FROM (B)(6) WAS OPERATING THE VARIANT II HEMOGLOBIN TESTING SYS. THE CUSTOMER PERSONNEL INDICATED THAT AFTER FINISHING THE DECONTAMINATION PROCEDURE SHE WAS STARTING TO RUN THE WHILE BLOOD PRIMER WHEN SHE GOT A RACK ERROR. WHILE TROUBLESHOOTING THE RACK ERROR SHE WAS SPLASHED IN THE FACE WITH LIQUID FROM THE DILUTION CHAMBER OF THE VARIANT II HEMOGLOBIN TESTING SYS. THE CUSTOMER PERSONNEL WAS NOT WEARING THE FACE MASK. SHE WASHED HER FACE WITH SOAP AND WATER. THE CUSTOMER PERSONNEL THEN WENT DOWN TO THE TRIAGE WHERE SHE WAS PRESCRIBED AN ANTI-TETANUS AND ANTI-HIV MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745879 VARIANT II HEMOGLOBIN TESTING SYS GLYCOSYLATED HEMOGLOBIN ASSAY LCP BIO-RAD LABORATORIES INC 13309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention