BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTMIX ZIKA RRT-PCR TEST (EUA)

    MDR report key: 6392444 · Received March 9, 2017

    Report

    Report Number
    2243471-2017-00005
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    January 25, 2016
    Report Date
    May 8, 2017
    Manufacturer
    OLFERT LANDT, TIB MOLBIOL SYNTHESELABOR GMBH
    Product Code
    POA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THE GENERATION OF THE FALSE POSITIVE RESULTS AND DRIFTING BASELINES IS CURRENTLY ON-GOING. A SUPPLEMENTAL REPORT WILL BE PROVIDED AT THE END OF THE INVESTIGATION. ROCHE MOLECULAR SYSTEMS HOLDS THE EUA FOR THE PRODUCT. (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IN THE UNITED STATES ALLEGED THE GENERATION OF FALSE POSITIVE WHEN TESTING PRESUMED NEGATIVE SAMPLES WITH THE LIGHTMIX ZIKA RRT-PCR TEST, EUA, FOLLOWING THE INSTRUCTIONS FOR USE AND THE FLUORESCENCE INTENSITY RATIO (FIR). PER THE INSTRUCTIONS FOR USE, WHEN THE FIR IS >/= 10 PERCENT, THE RESULT FOR THE ZIKA ASSAY IS CONSIDERED VALID AND THE INTERPRETATION OF THE SPECIMEN IS POSITIVE FOR ZIKA VIRUS. THE CUSTOMER CONFIRMED THAT THEY WERE TESTING CLINICAL SAMPLES; HOWEVER, THE FALSE POSITIVE ISSUE DID NOT OCCUR DURING PATIENT TESTING BUT WAS OBSERVED DURING THEIR VALIDATION TESTING. AS THIS CUSTOMER AND ANOTHER (REPORTED IN A SEPARATE MEDICAL DEVICE REPORT: 2243471-2017-00004) WERE GENERATING FALSE POSITIVE RESULTS WITH THE IMPLEMENTATION OF THE FIR, ROCHE INFORMED CUSTOMERS TO DISCONTINUE USE AND DISCARD ANY REMAINING INVENTORY OF THE LIGHTMIX ZIKA RRT-PCR TEST, EUA. ADDITIONALLY, ROCHE REQUESTED TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) TO WITHDRAW THIS TEST. ON 13-MAR-2017, ROCHE RECEIVED THE FDA'S NOTICE OF REVOCATION. A CAPA WAS INITIATED TO IDENTIFY THE ROOT CAUSE FOR THE FALSE POSITIVE RESULTS AND DRIFTING BASELINE. CORRECTIVE AND PREVENTIVE MEASURES WILL BE IMPLEMENTED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER IN (B)(6) IS OBSERVING A BASELINE DRIFT IN THE TARGET PCR CURVE, WHICH IS RAISING THE FLUORESCENCE INTENSITY RATIO (FIR) FOR PRESUMED, NEGATIVE SAMPLES (SERUM) TO BE CLOSE TO OR ABOVE THE 10 PERCENT CUT-OFF VALUE INDICATED IN THE LIGHTMIX ZIKA RRT-PCR TEST, EUA INSTRUCTIONS FOR USE. PER THE INSTRUCTIONS FOR USE, WHEN THE FIR IS >/= 10 PERCENT, THE RESULT FOR THE ZIKA ASSAY IS CONSIDERED VALID AND THE INTERPRETATION OF THE SPECIMEN IS POSITIVE FOR ZIKA VIRUS. THE CUSTOMER IS ONLY RUNNING SERUM SAMPLES. THE CUSTOMER SITE IS TESTING CLINICAL SAMPLES AND IS ONLY REPORTING NEGATIVE RESULTS, WHERE THE PCR GROWTH CURVES DO NOT HAVE A CP VALUE AND NO ASSOCIATED GROWTH CURVE, AND POSITIVE RESULTS, WHERE THE PCR GROWTH CURVES ARE SIGMOIDAL IN SHAPE. THERE IS NO INDICATION OF HARM OR INJURY, TO DATE, AS A RESULT OF THE ALLEGED FALSE POSITIVE ZIKA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174076 LIGHTMIX ZIKA RRT-PCR TEST (EUA) REAGENTS, ZIKA VIRUS NUCLEIC ACID POA OLFERT LANDT, TIB MOLBIOL SYNTHESELABOR GMBH NA 38161612

    Patients

    Seq Age Sex Outcome Treatment
    1