BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10064134 · Received May 17, 2020

    Report

    Report Number
    1221359-2020-00051
    Event Type
    Malfunction
    Date Received
    May 17, 2020
    Date of Event
    April 11, 2020
    Report Date
    May 17, 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: M118260 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: M118260 AND TEST BASE PART NUMBER: 190-430 / LOT: M118260 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: M118260 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 RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Description of Event or Problem · 1

    HOLD FOR CE 1.22A CUSTOMER SENT A CUMULATIVE REPORT OF TWELVE (12) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS TEN (10) DIFFERENT TESTING SITES. THIS REPORT REPRESENTS TWO (2) OF TWELVE (12). A FALSE NEGATIVE RESULT WITH A NASAL SWAB SAMPLE (TYPE AND ELUTION IN VTM NOT OTHERWISE SPECIFIED) ON THE ID NOW COVID-19 ASSAY WAS REPORTED BY A CUSTOMER. SPECIMEN COLLECTION AND TESTING WITH THE ID NOW COVID-19 ASSAY OCCURRED ON (B)(6) 2020. CONFIRMATION TESTING ON A NASOPHARYNGEAL (NP) SWAB ELUTED IN VTM (SWAB AND VTM TYPE NOT OTHERWISE SPECIFIED) WAS POSITIVE BY CORE LAB ON (B)(6) 2020. PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT, IMPACT AND OUTCOME, WAS 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 APRIL 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 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, THE ID NOW COVID-19 PRODUCT INSERT INCLUDES A LIMITATION THAT FALSE NEGATIVE RESULTS MAY OCCUR IF A SPECIMEN IS IMPROPERLY COLLECTED, TRANSPORTED OR HANDLED. FALSE NEGATIVE RESULTS MAY ALSO OCCUR IF AMPLIFICATION INHIBITORS ARE PRESENT IN THE SPECIMEN OR IF INADEQUATE LEVELS OF VIRUSES ARE PRESENT IN THE SPECIMEN. DUE TO THE RISK OF A POTENTIAL FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527701 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M118260 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1