BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM

    MDR report key: 11032382 · Received December 17, 2020

    Report

    Report Number
    2243471-2020-00509
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    December 8, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA201779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS TESTED TWICE WITH THE COBAS LIAT SARS/FLU TEST. THE FIRST TIME THE SAMPLE PRODUCED A POSITIVE RESULT FOR SARS WITH A CT OF 35.77, VERY DELAYED AND PROBABLY LOD. THE SECOND TEST WAS NEGATIVE FOR ALL TARGETS. THE CURVE DO NOT SHOW ANY ABNORMALITIES. THROUGH THE COURSE OF THE INVESTIGATION, A PRODUCT NON-CONFORMANCE WAS NOT IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    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 IN THE US ALLEGED A SAMPLE, TAKEN FROM A PREGNANT PATIENT, GENERATED A POSITIVE SARS RESULT WITH THE COBAS LIAT SARS-COV-2/FLU, WHICH UPON RETEST WITH THE COBAS LIAT SARS-COV-2/FLU AND A DIFFERENT ASSAY (BIOFIRE PCR TEST ), GENERATED NEGATIVE RESULTS. THE PATIENT WAS NOT KNOWN TO HAVE COVID SYMPTOMS AND WAS NOT EXPECTED TO HAVE COVID. THE RESULT WAS REPORTED AS NEGATIVE. CUSTOMER STATED THAT FOR THIS TEST THE LAB WAS USING 1 ML UTM IS FROM BD REF # 220526 BD VTM 1 ML FLEX MINI SWAB, AND THE SAMPLE WAS A NASAL PHARYNGEAL. PER THE INSTRUCTIONS FOR USE, BD TM UNIVERSAL VIRAL TRANSPORT (UVT) 3-ML COLLECTION KIT WITH A FLOCKED FLEXIBLE MINITIP SWAB REF# 220531 SHOULD BE USED. NO HARM OR INJURY WAS INDICATED. THE CT VALUE GENERATED FOR THE POSITIVE RESULT IS CONSIDERED LATE AND NEAR THE LIMIT OF DETECTION (LOD) OF THE TEST. THROUGH THE COURSE OF THE INVESTIGATION, A PRODUCT NON-CONFORMANCE WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1497223 COBAS SARS-COV-2 & INFLUENZA A/B TEST FOR USE ON THE COBAS LIAT SYSTEM REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA 00720Z

    Patients

    Seq Age Sex Outcome Treatment
    1