BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10027357 · Received May 5, 2020

    Report

    Report Number
    1221359-2020-00016
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 5, 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 SCARBOROUGH, INC. ON RETAINED KIT LOT M118538 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 NUMBER: M118538 AND TEST BASE PART NUMBER:190-430 / LOT NUMBER: M118538 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE (B)(6) PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO LOT NUMBER M118538 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS SCARBOROUGH, 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 (B)(4) TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DISCREPANT RESULTS WITH THE ID NOW COVID-19 TEST. THE CUSTOMER STATED A PATIENT TESTED (B)(6) (PATIENT COLLECTED SAMPLE; METHODOLOGY NOT OTHERWISE SPECIFIED) FOR COVID-19 ON (B)(6) 2020. THE PATIENT'S PHYSICIAN DETERMINED THEY WOULD MONITOR TREATMENT USING HYDROXYCHLOROQUINE AND Z-PACK. ON (B)(6) 2020, THE PATIENT HAD A NASOPHARYNGEAL (NP) SAMPLE ELUTED IN VTM COLLECTED FOR FOLLOW-UP COVID-19 TESTING AT (B)(6) LABORATORIES ((B)(6)). ON (B)(6) 2020, THE PATIENT'S PHYSICIAN DECIDED TO COLLECT AN ADDITIONAL NP SAMPLE (SWAB TYPE NOT OTHERWISE SPECIFIED) ELUTED VTM FOR ID NOW COVID-19 TESTING AS THE RESULTS FROM (B)(6) HAD NOT BEEN GENERATED. THE PATIENT SAMPLE FROM (B)(6) 2020 GENERATED (B)(6) RESULTS WHEN TESTED WITH ID NOW COVID-19 TEST ON THE ID NOW INSTRUMENT. ON (B)(6) 2020, THE PHYSICIAN WAS NOTIFIED THE SAMPLE FROM (B)(6) 2020 TESTED AT (B)(6) LABORATORIES GENERATED A (B)(6) RESULT. A NEW NP ELUTED IN VTM SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2020 AND RUN ON THE ID NOW COVID-19 TEST, GENERATING (B)(6) RESULTS ON THE ID NOW INSTRUMENT. THE SAME SAMPLE WAS RETESTED THREE (3) TIMES ON THREE (3) DIFFERENT SAMPLE RECEIVERS WITH THE ID NOW COVID-19 TEST, GENERATING THREE (3) CONSECUTIVE (B)(6) RESULTS. THE CUSTOMER REPORTED THAT NO REMEDIAL ACTION WAS TAKEN BASED ON THE ID NOW COVID-19 RESULTS AS THE PATIENT HAD INITIALLY TESTED (B)(6) FOR COVID-19 AND FOLLOW-UP TESTING WAS PERFORMED TO MONITOR TREATMENT EFFECTIVENESS. ON (B)(6) 2020, ABBOTT DIAGNOSTICS SCARBOROUGH, 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. WHILE THE ID NOW COVID-19 TEST WAS PERFORMING WITHIN CLAIMS, 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, 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. WHILE THE PATIENT WAS KNOWN TO BE COVID-19 POSITIVE, AND TESTING WAS PERFORMED TO MONITOR TREATMENT EFFECTIVENESS, FALSE NEGATIVE RESULTS ARE CONSIDERED REPORTABLE. 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. ADDITIONALLY, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487004 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M118538 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR