BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15498571 · Received September 28, 2022

    Report

    Report Number
    1221359-2022-04399
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    January 1, 2022
    Report Date
    October 18, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: EVENT DATE IS AN APPROXIMATION AS THE EVENT DATE(S) WAS NOT PROVIDED BY THE CUSTOMER. PMA/510K: SIMILAR PRODUCT TO 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1073255 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 KIT PART NUMBER 191-000 / LOT 1073255 AND TEST BASE PART NUMBER 190-430 / LOT 1073255. 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 1073255 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED FOR ANALYSIS. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED ON 12OCT2022 THAT THE POSITIVE ID NOW COVID-19 ASSAY RESULTS WERE CONFIRMED TO HAVE BEEN POSITIVE WITH CORRESPONDING POSITIVE PCR RESULTS. THE CUSTOMER INDICATED THAT THEY ARE NO LONGER ALLEGING ANY DEFICIENCIES WITH THE ID NOW COVID-19 ASSAY. THEREFORE, THE INITIAL REPORT OF FALSE POSITIVE RESULTS REPORTED ON MFR. REPORT NUMBER 1221359-2022-04399 HAS BEEN CONFIRMED TO ON LONGER BE CONSIDERED A REPORTABLE EVENT. THE EVENT WILL BE RE-EVALUATE IF ANY FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY ON UNKNOWN DATES. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ON 12OCT2022 THAT THE POSITIVE ID NOW COVID-19 ASSAY RESULTS WERE CONFIRMED TO HAVE BEEN POSITIVE WITH CORRESPONDING POSITIVE PCR RESULTS. THE CUSTOMER INDICATED THAT THEY ARE NO LONGER ALLEGING ANY DEFICIENCIES WITH THE ID NOW COVID-19 ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1746720 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1073255 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown