BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10036473 · Received May 7, 2020

    Report

    Report Number
    1221359-2020-00018
    Event Type
    Malfunction
    Date Received
    May 7, 2020
    Date of Event
    April 6, 2020
    Report Date
    May 5, 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

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M118529 WITH INTERNAL POSITIVE QUALITY CONTROL 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 M118529 AND TEST BASE PART NUMBER 190-430 / LOT M118529 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 M118529 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 RESULTS ON THREE (3) PATIENTS WITH THE ID NOW COVID-19 TEST. THIS REPORT REPRESENTS ONE (1) OF THREE (3). THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS ON A DIRECT NASAL SWAB AND NASOPHARYNGEAL (NP) SWAB IN 3ML VTM WITH THE ID NOW COVID-19 TEST. THE CUSTOMER STATED THE PATIENT HAD TWO (2) SAMPLE COLLECTIONS ON (B)(6) 2020; THE NASAL SWAB WAS FROM THE ID NOW COVID-19 TEST KIT AND THE NP SWAB WAS COPAN, ELUTED IN EITHER BD UNIVERSAL TRANSPORT MEDIA OR UNIVERSAL TRANSPORT MEDIA. CONFIRMATION TESTING WITH THE SAME VTM SAMPLE WAS POSITIVE ON COBRA 6800 RT PCR. ON (B)(6) 2020, A DIRECT NASAL SWAB (FROM THE ID NOW COVID-19 TEST KIT) AND NP SWAB (COPAN) IN 3ML VTM WAS RECOLLECTED AND RUN ON TWO (2) DIFFERENT ID NOW INSTRUMENTS. THE DIRECT NASAL SWAB GENERATED POSITIVE RESULTS WITH THE ID NOW COVID-19 TEST (ID NOW INSTRUMENT SN: (B)(4)); THE NP SWAB ELUTED IN VTM GENERATED NEGATIVE RESULTS (ID NOW INSTRUMENT SN: (B)(4)). THE VTM SAMPLE WAS REPEATED ON THE SAME INSTRUMENT AND REPEAT TESTING WAS NEGATIVE. ATTEMPTS TO GAIN FURTHER PATIENT INFORMATION REGARDING SYMPTOMS, TREATMENT AND/OR REMEDIAL ACTION, AND OUTCOME WERE NOT SUCCESSFUL. 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. DUE TO THE RISK OF A FALSE NEGATIVE RESULT POTENTIALLY LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497647 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M118529 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR