BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11678642 · Received April 16, 2021

    Report

    Report Number
    1221359-2021-00872
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 11, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT 1023084 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 190-000 / LOT: 1023084, TEST BASE PART NUMBER 190-430 / LOT: 1023084. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1023084 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN INVESTIGATION IS COMPLETE. REFERENCE MFR REPORTS: 1221359-2021-01006, 1221359-2021-01007, 1221359-2021-01008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVES WITH THE ID NOW COVID-19 ASSAY PERFORMED ON MULTIPLE DATES ON A DIRECT TESTED NASOPHARYNGEAL KITTED SWAB. THIS IS REPORT 1 OF 4. THE CUSTOMER REPORTED A FALSE POSITIVE WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGAEL KITTED SWAB. CONFIRMATION TESTING USING XPERT PLATFORM ON A NASOPHARYNGEAL SWAB GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THIS WAS PRE-ADMISSION TESTING ON PATIENTS WHO WERE SUSPECTED TO HAVE COVID-19. PER THE CUSTOMER THE PATIENT WAS ASYMTPOMATIC. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM DUE TO TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS A DELAY AND IMPACT OF TREATMENT DUE TO TEST RESULTS. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED OTHER THAN "INACCURATELY CHARACTERIZED AS COVID POSITIVE." PER THE CUSTOMER, THESE CASES WERE REPORTED TO US BY INFECTION CONTROL BECAUSE SOME OF THE POTENTIAL ISSUES WITH FALSE POSITIVES INCLUDING COHORTING PATIENTS WITH TRUE POSITIVE PATIENTS, HOSPITAL STAFF CONTACT INVESTIGATIONS, UNNECESSARY STAFF TESTING, DELAY/DISRUPTION IN TREATMENT FOR THE NON-COVID CONDITIONS, ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575161 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1023084 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other