BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13876345 · Received March 24, 2022

    Report

    Report Number
    1221359-2022-01557
    Event Type
    Malfunction
    Date Received
    March 24, 2022
    Date of Event
    March 3, 2022
    Report Date
    May 6, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORT NUMBER 1221359-2022-01556.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL IS BEING REPORTED TO PROVIDE THE INVESTIGATION CONCLUSION. ADDITIONAL DATA: B4, H2, H4, H6, H10. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1061310 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 190-000 / LOT 1061310, TEST BASE PART NUMBER 190-430 / LOT 1061310. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS RELATED TO KIT LOT 1061310 SHOWED THAT THE COMPLAINT RATE IS 0.002%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR TWO TESTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES TEST TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY FOR PERFORMED ON (B)(6) 2022 ON A NASAL SWAB. CONFIRMATION TESTING WAS PERFORMED VIA PCR (PLATFORM: CEPHEID) AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864354 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1061310 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown