BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 - 480T

    MDR report key: 13536585 · Received February 15, 2022

    Report

    Report Number
    2243471-2022-00216
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    January 17, 2022
    Report Date
    May 18, 2022
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG
    Product Code
    QJR
    PMA / PMN Number
    EUA200009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A SUPPLEMENTAL MDR WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THE CUSTOMER'S ISSUE HAS BEEN ALLEGED ON THE COBAS 6800 SYSTEM (PRODUCT CATALOG NUMBER 05524245001; UDI: (B)(4); PMA 510K: BK140196; PRODUCT CODE: MZA). THE TEST USED ON THE COBAS 6800 SYSTEM IS THE COBAS SARS-COV-2 FOR USE ON THE COBAS 6800-8800 SYSTEM (EUA(B)(4), PRODUCT CODE: QJR). THE PRODUCT CATALOG NUMBER FOR THE TEST (480T) IS 09343733190 AND THE UDI IS (B)(4). FACILITY NAME (B)(6) TRUNCATED DUE TO CHARACTER LIMITATIONS. (B)(4).

    Additional Manufacturer Narrative · 0

    THE ANALYTICAL UNIT OF THE COBAS ANALYZER WAS RETURNED AND AN INVESTIGATION ON THE UNIT DID NOT IDENTIFY AN ISSUE. A CAPA WAS INITIATED. PER THE INVESTIGATION, THE UNDERLYING TECHNICAL ROOT CAUSE IS OPTICAL SPATIAL CROSS TALK, WHICH IN SPECIFIC SITUATIONS (HIGH POSITIVITY RATE ON THE PLATE WITH SIMILAR CT VALUES OF TRUE POSITIVES WITH HIGH RFI VALUES AROUND A NEGATIVE SAMPLE) IN COMBINATION WITH THE ASAP (ASSAY SPECIFIC ANALYSIS PACKAGE) SETTING MAY LEAD TO FALSE POSITIVES. ASAP IS A SOFTWARE WHICH CONTAINS ALL ASSAY SPECIFIC PARAMETERS AND DEFINITIONS. BASED ON THE EVALUATION OF GLOBAL COMPLAINT DATA AND THE QUANTITY OF TESTS SOLD GLOBALLY, THE FREQUENCY OF OCCURRENCE IS ESTIMATED TO BE 0.00004% OR 1 IN 2.5 MILLION TEST RESULTS. A FALSE POSITIVE RATE ANYWHERE IN THIS RANGE WOULD NOT CAUSE AN IMPACT TO THE OVERALL PERFORMANCE OF THE TEST OR THE TEST¿S SPECIFICITY. WHILE A FALSE-POSITIVE RESULT FOR SARS-COV-2 COULD LEAD TO COHORTING WITH OTHERS WITH TRUE SARS-COV-2 INFECTION AND TRANSMISSION OF THE INFECTION TO THE ERRONEOUSLY DIAGNOSED PATIENT (INCLUDING THOSE AT HIGH RISK DUE TO COMORBIDITIES), PRIOR VACCINATION AND THE AVAILABILITY OF ANTIVIRAL MEDICATIONS AND OTHER TREATMENT MODALITIES CAN REDUCE THE LIKELIHOOD SEVERE ILLNESS, HOSPITALIZATION AND/OR DEATH. THE LATTER ALSO MITIGATES THE RISK FOR THOSE WHO MAY DEFER PROTECTIVE MEASURES BECAUSE OF ASSUMED NATURAL IMMUNITY. HOWEVER, PATIENTS WITH RISK FACTORS FOR SEVERE DISEASE WOULD BE LESS LIKELY TO RELAX THEIR PRECAUTIONS. TAKING THE LOW RATE OF FALSE POSITIVE OCCURRENCE AND THE LOW PROBABILITY OF SUBSEQUENT PATIENT SAFETY IMPACTS TOGETHER, THE FALSE POSITIVES ARE UNLIKELY TO CAUSE ADVERSE TRANSIENT OR SEVERE ADVERSE EVENTS. ADDITIONALLY, NO HARM WAS INDICATED IN THE CURRENT CASE. AN UPDATED ASAP VERSION WITH OPTIMIZED SETTINGS WILL BE MADE AVAILABLE. (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 IN GERMANY ALLEGED THE GENERATION OF FALSE POSITIVE TARGET 1 (SARS-COV-2) RESULTS FOR SAMPLES TESTED WITH THE COBAS SARS-COV-2 - 480T (SN (B)(4)). THE SAMPLES WERE INCLUDED IN 5 TEST RUNS/CONTROL BATCHES. UPON REPEAT TESTING, USING THE SAME AND A DIFFERENT COBAS 6800/8800 SYSTEM, NEGATIVE RESULTS WERE GENERATED IN TARGET 1. IT WAS NOTED THAT RESULTS WERE REPORTED AS EITHER NEGATIVE OR BORDERLINE FOR A MAJORITY OF THE SAMPLE. FOR ONE SAMPLE, IT IS UNKNOWN IF RESULTS WERE REPORTED. NO HARM OR INJURY WAS INDICATED. PER FDA EUA GUIDANCE, 5 MDRS WILL BE FILED, ONE FOR EACH OF THE 5 TEST RUNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585048 COBAS® SARS-COV-2 - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H24053

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown