BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS® SARS-COV-2 - 480T

    MDR report key: 13175656 · Received January 6, 2022

    Report

    Report Number
    2243471-2022-00038
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Date of Event
    December 9, 2021
    Report Date
    January 6, 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
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ISSUE HAS BEEN ALLEGED ON THE COBAS 8800 SYSTEM (PRODUCT CATALOG NUMBER 05412722001; UDI: (B)(4); PMA 510K: BK140195; PRODUCT CODE: MZA). THE TEST USED ON THE COBAS 6800/8800 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). REVIEW OF THE INSTRUMENT DATA SN (B)(4) CONFIRMED THAT 2 USED TIP RACKS WERE MANUALLY REMOVED FROM THE COBAS ANALYZER, THEN LATER THE CUSTOMER RELOADED THEM BACK ON THE ANALYZER. THE REUSE OF THE CONSUMABLE CAUSED THE LATER 2 RUN BATCHES, 6314 AND 6316, TO BE ABORTED DUE TO THE MISSING LIQUID WASTE INSERTS. AN INVESTIGATION OF THE ISSUE DID NOT IDENTIFY ANY PRODUCT PROBLEM AS THE PRODUCT LABELING (SAFETY MANUAL AND USER ASSISTANCE) INSTRUCTS THE OPERATOR NOT TO RELOAD USED CONSUMABLES. THE USER ASSISTANCE ALSO PROVIDES INSTRUCTIONS ABOUT LOADING AND UNLOADING CONSUMABLES FROM THE ANALYZER AND APPROPRIATELY DISCARDING THEM. THE SYSTEM PERFORMED AS INTENDED AND ABORTED THE RUN WHERE THE USED CONSUMABLES WERE UNINTENTIONALLY REUSED BY THE OPERATOR. ALTHOUGH THE INSTRUMENT ABORTED THE RUNS AS EXPECTED, THE CUSTOMER TESTED THE POTENTIALLY CONTAMINATED PRIMARY TUBES TO THE SECOND COBAS 8800 AT THE CUSTOMER SITE TO GENERATE RESULTS AND RECOGNIZED THE MISTAKE LATER. NO SPECIFIC PATIENT IDENTIFIABLE DATA IS AVAILABLE; THERE WAS NO ALLEGED IMPACT TO HEALTH. NO RETEST RESULTS WERE PROVIDED TO CONFIRM WHETHER THE INITIAL POSITIVE RESULTS WERE INCORRECT. TWO BATCH MDRS, ONE PER ALLEGED RUN, ARE BEING FILED. (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 (B)(6) REPORTED POTENTIAL FALSE POSITIVE SARS-COV-2 RESULTS WHEN USING THE COBAS SARS-COV-2 TEST FOR USE ON THE COBAS 6800/8800 SYSTEMS. THE CUSTOMER EXPERIENCED A RUN ABORT AND REUSED THE USED TIP RACKS TO PIPET SAMPLES FROM PRIMARY TUBES IN THE FOLLOWING 2 RUNS, POTENTIALLY CONTAMINATING THE SAMPLES IN THE PRIMARY TUBES. THESE SUBSEQUENT 2 RUNS WERE ABORTED BY THE ANALYZER BECAUSE OF MISSING WASTE RACK INSERTS. THE AFFECTED SAMPLES IN THE PRIMARY TUBES WERE LATER LOADED AND TESTED ON A DIFFERENT COBAS 8800 ANALYZER. REVIEW OF THE TEST RESULTS FROM THE NEW TESTING RUNS SHOWED 27 POSITIVE RESULTS WERE GENERATED FROM THESE POTENTIALLY CONTAMINATED SAMPLES. THE RESULTS WERE REPORTED OUT. ALL 27 SAMPLES WERE LATER RECOLLECTED TO BE RETESTED. ALTHOUGH REQUESTED, THE RETEST RESULTS WERE NOT PROVIDED. IT IS UNKNOWN THE NUMBER OF SAMPLES, IF ANY, HAVE DISCREPANT RESULTS IN THE RETEST. NO HARM WAS INDICATED. AN INVESTIGATION WAS PERFORMED FOR THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739574 COBAS® SARS-COV-2 - 480T REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG NA H15895

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown