BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10377247 · Received August 6, 2020

    Report

    Report Number
    1221359-2020-00212
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 7, 2020
    Report Date
    August 6, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M120173 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 M120173 AND TEST BASE PART NUMBER 190-430 / LOT M120173 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 M120173 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M120173 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

    A CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 TEST. THE CUSTOMER REPORTED THAT A DIRECT NASAL KIT-PROVIDED SWAB SAMPLE GENERATED A POSITIVE ID NOW COVID-19 RESULT. REPEAT TESTING ON THE SAME DAY WITH A NEWLY COLLECTED DIRECT NASAL KIT-PROVIDED SWAB SAMPLE GENERATED A NEGATIVE ID NOW COVID-19 RESULT. THE CUSTOMER STATED THAT NO RESULTS WERE AVAILABLE FROM CONFIRMATION TESTING. THE PATIENT WAS REPORTED TO BE AYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO SERIOUS INJURY OR DEATH AND THERE WAS NO IMPACT OR DELAY TO PATIENT TREATMENT. ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT, IMPACT AND OUTCOME WAS UNKNOWN. ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND TESTED WITH AN ALTERNATIVE FDA AUTHORIZED MOLECULAR ASSAY, IF NECESSARY FOR CLINICAL MANAGEMENT, INCLUDING INFECTION CONTROL. 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. 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. SINCE IT IS UNKNOWN WHICH RESULT IS CORRECT, UNEXPLAINED CONFLICTING RESULTS SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836006 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M120173 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR