BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10050126 · Received May 12, 2020

    Report

    Report Number
    1221359-2020-00030
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 11, 2020
    Report Date
    May 11, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT M118741 AND TEST BASE PART NUMBER 190-430 / LOT M118741 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M118741 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT IN19000 V1.0 RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY WITH TWO (2) SYMPTOMATIC PATIENTS. THIS REPORT REPRESENTS ONE (1) OF TWO (2). THE CUSTOMER REPORTED THAT A NASOPHARYNGEAL SWAB ELUTED IN 3ML VTM (TYPE NOT OTHERWISE SPECIFIED) GENERATED NEGATIVE RESULTS WITH THE ID NOW COVID-19 ON A CLINICALLY SYMPTOMATIC PATIENT. CONFIRMATION TESTING WITH ROCHE AND DIASORIN GENERATED "WEAK POSITIVES." A NEW SAMPLE WAS COLLECTED (SAMPLE TYPE NOT OTHERWISE SPECIFIED) AND RETESTED WITH THE ID NOW COVID-19 ASSAY, GENERATING POSITIVE RESULTS. ADDITIONALLY, THE CUSTOMER STATED THE INITIAL NP SWAB ELUTED IN 3ML VTM WAS REPEATED WITH THE ID NOW COVID-19 ASSAY, GENERATING POSITIVE RESULTS. THE PATIENT WAS NOTED TO HAVE BEEN ON QUARANTINE. PATIENT TREATMENT AND OUTCOME WERE UNKNOWN. ABBOTT DIAGNOSTICS (B)(4), INC. RECEIVED AUTHORIZATION FROM THE FDA FOR THE REMOVAL OF SWABS ELUTED IN VTM AS AN APPROPRIATE SAMPLE TYPE FROM THE ID NOW COVID TEST IN (B)(6) 2020. WHILE THE ID NOW COVID-19 TEST WAS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT IN19000 V1.0 RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION, THE CHANGE WAS A PROACTIVE MEASURE TO REMOVE THE RISK OF POTENTIAL REDUCED SENSITIVITY, OR FALSE NEGATIVE IN THE EVENT OF A LOW ANALYTE CONCENTRATION AS VTM IS KNOWN TO DILUTE THE PATIENT SAMPLE. CUSTOMERS WERE INFORMED OF THE CHANGE THROUGH A TECHNICAL BULLETIN, TB000041 V1.0, INDICATING: "THE SPECIMEN COLLECTION AND HANDLING FOR THE ID NOW" COVID-19 TEST HAS CHANGED. SWABS ELUTED IN VTM ARE NO LONGER AN APPROPRIATE SAMPLE TYPE. PLEASE REFER TO THE UPDATED PRODUCT INSERT INCLUDED IN THIS KIT. ID NOW COVID-19 IS INTENDED FOR TESTING A SWAB DIRECTLY WITHOUT ELUTION IN VIRAL TRANSPORT MEDIA AS DILUTION WILL RESULT IN DECREASED DETECTION OF LOW POSITIVE SAMPLES THAT ARE NEAR THE LIMIT OF DETECTION OF THE TEST. DUE TO THIS CHANGE, DISPOSABLE TRANSFER PIPETTES ARE NO LONGER INCLUDED IN THE KIT." ADDITIONALLY, ALL ID NOW COVID-19 AFFILIATED LABELING WAS UPDATED TO REFLECT THE REMOVAL OF SWABS ELUTED IN VIRAL TRANSPORT MEDIA. THE EVENTS OF THIS CASE TOOK PLACE PRIOR TO THE REMOVAL OF THE ID NOW COVID-19 VTM CLAIM. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION. CONFLICTING RESULTS INDICATE A MALFUNCTION OF ONE OF THE TESTS AS IT IS EXPECTED THAT TESTING THE SAME PATIENT SAMPLE OR A SECOND SAMPLE FROM THE SAME PATIENT TESTED ON THE SAME DAY AS THE ORIGINAL SAMPLE WOULD RETURN THE SAME RESULT. DUE TO THE POTENTIAL RISK OF A FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE. PER CA-0290-SCR, REV. B.0, #3

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509535 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M118741 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1