BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEXA FLU A/B AND RSV DIRECT ASSAY

    MDR report key: 4379609 · Received December 29, 2014

    Report

    Report Number
    2023365-2014-00007
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    FOCUS DIAGNOSTICS, INC.
    Product Code
    OCC
    PMA / PMN Number
    K120413
    Removal / Correction Number
    Z-0846-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT GENDER INFORMATION NOT REPORTED. THE INVESTIGATION OF SIMPLEXA FLU A/B AND RSV DIRECT KIT (MOL2650) SUGGESTED THAT THE ROOT CAUSE FOR THE OCCURRENCE OF FALSE POSITIVES (AND SUB-AMPLIFICATIONS) WERE DUE TO THE LOT TO LOT VARIABILITY OF THE SCORPION PRIMERS. TO MITIGATE THE OCCURRENCE OF FALSE POSITIVES (AND SUB-AMPLIFICATIONS), FOCUS DX REPLACED THE RECOMBINANT TAQ POLYMERASE USED IN THE MOL2651 REACTION MIX WITH HOT-START TAQ POLYMERASE AND REDUCED PRODUCTION TIME FOLLOWING BULK MOL2651 FORMULATION TO 2 HOURS. ADDITIONALLY, FOCUS DX NOW EMPLOYS MORE EXTENSIVE TESTING WITH NO TEMPLATE CONTROL (NTC) IN THE QC KIT RELEASE CRITERIA. THESE CORRECTIVE AND PREVENTATIVE ACTIONS ARE EFFECTIVE IN MITIGATING THE EFFECTS POSED BY THE POTENTIAL LOT TO LOT VARIABILITY OF THE SCORPIONS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY ARE SEEING LOW LEVEL POSITIVE RSV RESULTS IN MOST OF THEIR SAMPLES FOR PATIENT TESTING. TEN (10) SAMPLES WERE REPEATED USING A DIFFERENT KIT MODEL AND THE RESULTS WERE RSV NEGATIVE. THE LABORATORY DID NOT REPORT THE RESULTS TO THE DOCTOR. A VOLUNTARY RECALL HAS BEEN PERFORMED RELATED TO THE REPORTED LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855456 SIMPLEXA FLU A/B AND RSV DIRECT ASSAY IN-VITRO-DIAGNOSTIC TEST, INFLUENZA OCC FOCUS DIAGNOSTICS, INC. MOL2650 24495

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK