BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11678619 · Received April 16, 2021

    Report

    Report Number
    1221359-2021-01006
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 27, 2021
    Manufacturer
    ABBOTT DAIGNOSTICS 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

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR REPORTS: 1221359-2021-00872, 1221359-2021-01007, 1221359-2021-01008.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVES RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS ON MULTIPLE DATES. THIS MFR REPORT ADDRESSES PATIENT 2 OF 4. FROM (B)(6) 2021 TO (B)(6) 2021 WE HAD ANOTHER 4 FALSE POSITIVE ID BASED ON TESTING 2 OR 3 OTHER SYSTEMS FROM PATIENTS BEING ADMITTED FOR CONDITIONS UNRELATED TO COVID-19. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT NASOPHARYNGEAL KITTED SWAB. CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY USING LIAT, BD MAX. THIS GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THIS IS PRE-ADMISSION TESTING ON PATIENTS WHO WERE SUSPECTED TO HAVE COVID-19. PER THE CUSTOMER THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER CONFIRMED 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 CUSTOMERS, 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
    574809 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DAIGNOSTICS SCARBOROUGH, INC 1023084 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1