BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERPESELECT 2 ELISA IGG

    MDR report key: 4379411 · Received December 29, 2014

    Report

    Report Number
    2023365-2014-00053
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    November 17, 2011
    Report Date
    December 1, 2011
    Manufacturer
    FOCUS DIAGNOSTICS, INC.
    Product Code
    MXJ
    PMA / PMN Number
    K021486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCE MATERIAL REPORTS OF DISCREPANCIES DURING THE MANUFACTURE OF THE LOT. NO COMPLAINT TRENDS WERE OBSERVED WITH THE CATALOG NUMBER OR FOR THE LOT. THE CUSTOMER'S RUN FILES WERE REVIEWED AND THE KIT CONTROLS WERE FUNCTIONING PER THE QC PERFORMANCE CRITERIA. NO DISCREPANCIES WERE OBSERVED WITH THE KIT CHEMISTRY. THE CUSTOMER WAS ADVISED TO TROUBLESHOOT THE DSX AUTOMATION WITH RESPECT TO THE PIPETTING OF SAMPLES. THE CUSTOMER WAS ALSO ADVISED TO REPEAT THE RUN MANUALLY, PREFERABLY IN DUPLICATE OR TRIPLICATE. THE LAB SUPERVISOR AGREED WITH THE ANALYSIS. THE USER IS RESPONSIBLE FOR ASSAY PERFORMANCE WHEN AN AUTOMATED SYSTEM IS USED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE ASSAY WAS RUN ON (B)(6) 2011 AND THE INITIAL RESULT WAS (B)(6) WITH AN INDEX 2.88. THE ASSAY WAS RUN AGAIN ON (B)(6) 2011 AND THE RESULT WAS (B)(6) WITH AN INDEX OF 0.06. THE PATIENT SAMPLE WAS STORED AT -20C (SERUM SEPARATED) BETWEEN (B)(6) 2011. BOTH ASSAYS WERE RUN USING THE SAME KIT LOT. BOTH (B)(6) RESULTS WERE REPORTED TO THE DOCTOR, WITH A SPAN OF APPROXIMATELY 2 WEEKS BETWEEN THE REPORTS. IT IS UNKNOWN IF THE PATIENT RECEIVED TREATMENT BASED ON THE (B)(6) TEST RESULT. THIS MDR IS BEING REPORTED FOR A POSSIBLE (B)(6) TEST RESULT FROM THE TESTS PERFORMED ON (B)(6) 2011 FOR THE (B)(6). THIS IS A CONSERVATIVE DECISION, BASED ON THE FACT THAT NEEDED TREATMENT MIGHT BE DISCONTINUED. IF THE PATIENT WAS PREGNANT, IT MAY RESULT IN SERIOUS INDIRECT HARM TO THE FETUS. THE PATIENT INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854635 HERPESELECT 2 ELISA IGG HERPES SIMPLEX VIRUS SER. ASSAY MXJ FOCUS DIAGNOSTICS, INC. EL0920G 113148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK