BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 & INFLUENZA A/B

    MDR report key: 13980594 · Received April 1, 2022

    Report

    Report Number
    2243471-2022-00356
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    February 8, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QLT
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGHOUT THE DATA ANALYSIS, A SYSTEMATIC ISSUE WAS NOT OBSERVED AND A PRODUCT PROBLEM WAS NOT FOUND. FURTHER INVESTIGATION DID NOT SHOW INDICATIONS OF A SYSTEM-RELATED ISSUE AND A SYSTEMIC ISSUE WAS NOT IDENTIFIED FOR REAGENT LOT 11130T. THE MOST LIKELY CAUSE FOR THE DISCREPANCY OBSERVED IS DUE TO THE SAMPLES HAVING A LOW VIRAL LOAD, EITHER FROM A PATIENT WITH A LOW TITER OR FROM LAB CROSS-CONTAMINATION. NOTE THAT SAMPLES NEAR OR BELOW THE LOD OF THE TEST MAY GENERATE WAVERING RESULTS ON REPEAT TESTING. (B)(4).

    Description of Event or Problem · 0

    IN LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT EMERGENCY USE AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTIC TESTS, THE AGENCY HAS REQUESTED HEIGHTENED REPORTING BEYOND THE REASONABLY SUGGESTS REQUIREMENTS OF 803 TO INCLUDE ALLEGATIONS OF FALSE POSITIVE OR FALSE NEGATIVE RESULTS INDEPENDENT OF HARM OR MALFUNCTION OR OFF-LABEL USE. PURSUANT TO THE AGENCY¿S INSTRUCTION, WE HEREBY SUBMIT THIS MDR. A CUSTOMER FROM CHILE ALLEGED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE USING THE COBAS® SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS® LIAT® SYSTEM. THE CUSTOMER REPORTED, THE INITIAL SAMPLE WAS PROCESSED ON (B)(6) USING LOT 11130T, COBAS® LIAT® S/N(B)(4) AND GENERATED INFLUENZA A POSITIVE. THE SAME SAMPLE WAS RERUN TWICE; FIRST REPEAT ON (B)(6) WITH MPURE-12 AND LUMINEX AMPLIFICATION KIT RESULTING IN INFLUENZA A NEGATIVE. SECOND REPEAT ON (B)(6), WITH COBAS® LIAT® S/N (B)(4) WITH ALL 3 TARGETS REPORTED AS NEGATIVE. POSITIVE INFLUENZA A RESULT WAS REPORTED TO THE PATIENT AND/OR MEDICAL PERSONNEL TREATING THE PATIENT. NO APPARENT HARM OR INJURY OCCURRED IN RELATION TO THE EVENT. THE SAMPLE WAS COLLECTED AS A NASOPHARYNGEAL TYPE IN MTV MEDIA, WHICH IS CONSIDERED AN OFF-LABEL PRACTICE. THE METHOD SHEET INDICATES THAT ; THIS TEST IS INTENDED TO BE USED FOR THE DETECTION OF SARS-COV-2, INFLUENZA A AND INFLUENZA B RNA IN NASAL AND NASOPHARYNGEAL SWAB SAMPLES COLLECTED IN A COPAN UTM-RT SYSTEM (UTM-RT) OR BD¿ UNIVERSAL VIRAL TRANSPORT SYSTEM (UVT) OR THERMO FISHER¿ SCIENTIFIC REMEL¿ MEDIA, OR THOMAS SCIENTIFIC MANTACC¿ PREMEASURED 3 ML 0.9% PHYSIOLOGICAL SALINE SOLUTION. TESTING OF OTHER SAMPLE OR MEDIA TYPES MAY LEAD TO INACCURATE RESULTS. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER'S ALLEGATION. PER THE FDA EUA GUIDANCE 1 MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1486889 COBAS® SARS-COV-2 & INFLUENZA A/B COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES QLT ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 11130T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown