BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-SARS-COV-2

    MDR report key: 10275392 · Received July 15, 2020

    Report

    Report Number
    1823260-2020-01696
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 31, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    QKO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WAS SUCCESSFUL ON (B)(6) 2020. THE INVESTIGATION FOUND THAT THE CUSTOMER RESULTS WERE REPRODUCIBLE WITH BOTH PATIENT SAMPLES. A RAPID ASSAY FROM CREATIVE DIAGNOSTICS AND AN INDEPENDENT IN-HOUSE ROCHE ASSAY WERE ALSO USED. PATIENT #1: THE INVESTIGATION FOUND NO SIGNS OF A SARS-COV-2 INFECTION IN OTHER PERFORMED ASSAYS. HOWEVER, A NEGATIVE EFFECT OF THE BLOPRESS/ AMLODIPIN-THERAPY ON THE IMMUNE SYSTEM CANNOT BE RULED OUT. PATIENT #2: THE INVESTIGATION FOUND CLEAR REACTIVE RESULTS IN ALL THE PERFORMED ASSAYS, AND THERE IS ENOUGH EVIDENCE TO CONFIRM AN INFECTION WITH SARS-COV-2. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SARS-COV-2-IGM/IGG RAPID TEST METHOD FROM NAL VON MINDEN IS NOT ON THE LIST OF EUA PRODUCTS. THE PATIENT SAMPLES WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS ANTI-SARS-COV-2 RESULTS FOR 2 PATIENTS ON A COBAS 8000 E 801 MODULE, SERIAL NUMBER (B)(4). PATIENT 1 RESULTS: THE SAMPLE WAS COLLECTED ON (B)(6) 2020. THE PATIENT SAMPLE PRODUCED A POSITIVE RESULT OF 2.73 COI USING THE ELECSYS ANTI-SARS-COV-2 METHOD. THE SAME PATIENT SAMPLE PRODUCED A NEGATIVE RESULT USING THE SARS-COV-2-IGM/IGG RAPID TEST METHOD FROM NAL VON MINDEN. PATIENT 2 RESULTS: THE SAMPLE WAS COLLECTED ON (B)(6) 2020. THE PATIENT SAMPLE PRODUCED A POSITIVE RESULT OF 47.5 COI USING THE ELECSYS ANTI-SARS-COV-2 METHOD. THE SAME PATIENT SAMPLE PRODUCED A NEGATIVE RESULT USING THE SARS-COV-2-IGM/IGG RAPID TEST METHOD FROM NAL VON MINDEN. THE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743860 ELECSYS ANTI-SARS-COV-2 CORONAVIRUS SEROLOGICAL REAGENT QKO ROCHE DIAGNOSTICS NA 496292

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR AMLODIPINE (PATIENT 1)| BLOPRESS (PATIENT 1)