BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIQUICHEK SPINAL FLUID CONTROL LEVEL 1

    MDR report key: 6974280 · Received October 24, 2017

    Report

    Report Number
    2016706-2017-00003
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 10, 2017
    Report Date
    October 24, 2019
    Manufacturer
    BIO-RAD LABORATORIES INC
    Product Code
    JJY
    UDI-DI
    00847661001584
    PMA / PMN Number
    K990888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIO-RAD SENT SAMPLES OF LIQUICHEK SPINAL FLUID LOT 55660 TO TWO DIFFERENT LABS USING TWO DIFFERENT TEST METHODS (HOLOGIC PROCLEIX GRIFOLS NAT AND ROCHE MPX V2.0 MULTIPLEX NAT) TO ANALYZE FOR (B)(6). RESULTS WERE REPORTED AS (B)(6). BIO-RAD ALSO REVIEWED THE VENDOR CERTIFICATE OF ANALYSIS (COA) FOR ALL HUMAN SOURCED RAW MATERIALS USED. THE RAW MATERIALS INDICTED (B)(6) RESULTS FOR (B)(6) USING FDA APPROVED METHODS.

    Description of Event or Problem · 1

    ON OCTOBER 10, 2017 BIO-RAD (B)(4) RECEIVED A REPORT FROM THE UNIVERSITY (B)(6) IN THE (B)(6) OF AN EYE SPLASH INVOLVING LIQUICHEK SPINAL FLUID CONTROL THAT HAD OCCURRED APPROXIMATELY 4 WEEKS EARLIER. A LAB TECHNICIAN HAD SPLASHED THE SPINAL FLUID CONTROL INTO HER EYE. SHE HAD RECENTLY DEVELOPED A "RASH AND TEMPERATURE RISE CONSISTENT WITH (B)(6)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750269 LIQUICHEK SPINAL FLUID CONTROL LEVEL 1 MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) JJY BIO-RAD LABORATORIES INC 55661 00847661001584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other