BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROGENICS

    MDR report key: 1160883 · Received January 12, 2007

    Report

    Report Number
    2937369-2006-00001
    Event Type
    Other
    Date Received
    January 12, 2007
    Date of Event
    July 17, 2006
    Report Date
    January 9, 2007
    Manufacturer
    MICROGENICS, THERMO FISHER SCIENTIFIC, DIAGNOSTICS DIV
    Product Code
    DIS
    PMA / PMN Number
    K960664
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FORM HAS BEEN COMPLETED AT THE BEHEST OF FDA THAT IT ACCOMPANY OUR REPLY TO ITS REQUEST FOR ADD'L INFO. PROD WAS USED INAPPROPRIATELY ACCORDING TO THE DIRECTIONS OF THE PACKAGE INSERT - THERE WAS NO DEVICE FAILURE AND NO MDR-REPORTABLE EVENT OCCURRED. A COPY OF FDA'S 14-NOV-2006 REQUEST FOR ADD'L INFO AND A RESPONSE TO IT ARE ENCLOSED. THERMOFISHER (FORMERLY MICROGENICS) HAS DETERMINED THAT THE EVENT IS NOT ATTRIBUTABLE TO THE DEVICE. CUSTOMER HAS INSUFFICIENT AMOUNT OF THE ORIGINAL SAMPLE TO SEND FOR MICROGENICS IN-HOUSE TESTING. CUSTOMER SENT A NEW SAMPLE FROM SAME PT. CUSTOMER STATED THAT THIS NEW SAMPLE TESTED NEGATIVE BY THE DRI SERUM TOX ASSAY, BUT THEIR REFERENCE LAB REPORTED, IT WAS 6.0 UM/ML. MICROGENICS TESTED IN HOUSE ON HITACHI 717 INSTRUMENT AND THE RESULT WAS NEGATIVE, BELOW THE CUT-OFF CALIBRATOR OF 1.0 UG/ML. GC/MS TESTING OF THE PROD SAMPLE WAS REPEATED BY MICROGENICS TO BE 5.7 UG/ML. CUSTOMER DECIDED TO STOP USING ASSAY AS THEY BELIEVE IT IS NOT PERFORMING TO PACKAGE INSERT SPEC. DR STATED SHE IS ALSO IN THE PROCESS OF SENDING IN A MDA TO THE FDA. CUSTOMER STATED THAT THEY USED THE ASSAY TO MONITOR THE LEVEL OF PENTOBARBITAL. PENTOBARBITAL IS BEING GIVEN TO PTS IN A COMA TO KEEP BRAIN SWELLING DOWN. PENTOBARBITAL LEVEL HAS TO BE BELOW A CERTAIN LEVEL BEFORE ORGANS CAN BE HARVESTED. MICROGENICS EXPLAINED THAT THE LEVEL OF 5 UG/ML PENTOBARBITAL LISTED IN THE PACKAGE INSERT IS BASED ON THE CUT-OFF LEVEL OF 1 UG/ML AND AT HIGHER CONCENTRATIONS THE X-REACTIVITY WOULD BE DIFFERENT. IN ADDITION, THE ASSAY IS NOT INTENDED FOR PENTOBARBITAL MONITORING. CUSTOMER HAS DECIDED TO USE 3 UG/ML AS CUT-OFF SINCE IT IS THE LEVEL TO DISTINGUISH TOXIC SAMPLES. MICROGENICS INFORMED CUSTOMER THAT THE HIGHER CUT-OFF WOULD CHANGE THE ASSAY PROFILE AND THE SENSITIVITY OF THE OTHER BARBITURATES FROM THE LEVELS LISTED IN THE PACKAGE INSERT. THOSE LEVELS ARE INDICATED FOR THE 1.0 UG/ML CUT-OFF. CUSTOMER STATES THAT THE LAB HAS STOPPED USING THIS ASSAY AND THAT DR WILL CALL BACK IF SHE HAS MORE INFO. DRI SERUM BOX BARBITURATE ASSAY IS A CLASS ASSAY THAT DETECTS DIFFERENT BARBITURATES AT DIFFERENT SENSITIVITIES. THE ASSAY IS NOT INTENDED FOR MONITORING A PARTICULAR BARBITURATE ANALYTE. THE ASSAY UTILIZES A CALIBRATOR SPIKED WITH ON OF THE BARBITURATES AT A RECOMMENDED CONCENTRATION OF 1 UG/ML. BY THE CUSTOMER CHANGING THE CUTOFF CALIBRATOR TO A HIGHER LEVEL FROM 1 TO 3 UG/ML (NOT RECOMMENDED BY THE PROD PACKAGE INSERT), THE ASSAY SENSITIVITY LEVEL INCREASED AS WELL. REMEDIAL ACTION: CUSTOMER WAS INFORMED THAT THEY ARE USING THE ASSAY INCORRECTLY. IT IS AN INAPPROPRIATE USE OF THIS TEST FOR MONITORING. ACCORDING TO THE DIRECTIONS OF THE PACKAGE INSERT - USE FOR SERUM TOXICOLOGY ASSAY ONLY IN THE ER SITUATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE ASSAY PT RESULT, USING THE ADVIA 2400 INSTRUMENT, WAS NEGATIVE AT 2.8 UG/ML, BELOW THE CUT-OFF CALIBRATOR OR 3.0 UG/ML, BY THE DRI SERUM TOX BARBITURATE ASSAY. HOWEVER, THE CONFIRMATION OF THE RESULT WAS 28 UG/ML OF PENTOBARBITAL BY GC/MS (GAS CHROMATOGRAPHY/MASS SPECTROMETRY). CONFIRMATION BY GC/MS IS THE GOLD STANDARD OF TESTING FOR THIS TYPE OF ASSAY. THE CUSTOMER USED THE 3.0 UG/ML CUT-OFF CALIBRATOR INSTEAD OF THE RECOMMENDED CUT-OFF BY MICROGENICS PACKAGING INSERT OF 1.0 UG/ML; INAPPROPRIATE USE OF THE PROD. CUSTOMER STATED THAT THE PACKAGE INSERT STATES THAT THE RESULT WOULD BE POSITIVE FOR PENTOBARBITAL AT A CONCENTRATION OF 5 UG/ML (WHICH IS CORRECT ONLY FOR THE CUT-OFF AT 1.0 UG/ML). PT IS KNOWN TO TAKE BARBITURATES AND IT IS A NEONATE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROGENICS DRI BARBITURATE SERUM TOX ASSAY DIS MICROGENICS, THERMO FISHER SCIENTIFIC, DIAGNOSTICS DIV NA 56561925

    Patients

    Seq Age Sex Outcome Treatment
    1