BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-SARS-COV-2 S

    MDR report key: 11768592 · Received May 4, 2021

    Report

    Report Number
    1823260-2021-01335
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 25, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QKO
    PMA / PMN Number
    EUA202698
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QC DATA WERE REQUESTED BUT NOT PROVIDED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-SARS-COV-2 S AND ELECSYS ANTI-SARS-COV-2 RESULTS FOR ONE PATIENT WITH THE COBAS 6000 E601 MODULE. THIS MEDWATCH WILL COVER ANTI-SARS-COV-2 S. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-54696 FOR INFORMATION ON THE ANTI-SARS-COV-2 RESULTS. ON (B)(6) 2021, THE PCR RESULT WAS POSITIVE. ON (B)(6) 2021, THE ANTI-SARS-COV-2 S RESULT WAS NEGATIVE. THE SAMPLE WAS TESTED WITH BECKMANN IGG WITH A RESULT OF 4.48 COI (POSITIVE) AND AN ABBOTT S1RBD WITH A RESULT OF 152 UA/ML (POSITIVE). THE IGM RESULT WAS NEGATIVE. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664568 ELECSYS ANTI-SARS-COV-2 S CORONAVIRUS SEROLOGICAL REAGENT QKO ROCHE DIAGNOSTICS NA 516394

    Patients

    Seq Age Sex Outcome Treatment
    1