BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12914473 · Received December 1, 2021

    Report

    Report Number
    1221359-2021-03645
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    October 31, 2021
    Report Date
    December 1, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1047041 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: 1047041, TEST BASE PART NUMBER 190-430 / LOT: 1047041. 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 1047041 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. A REVIEW OF COMPLAINTS AGAINST THE KIT LOTS FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. PLEASE REFERENCE ALL MFR. REPORT #S: 1221359-2021-03628, 1221359-2021-03629, 1221359-2021-03644, 1221359-2021-03645 AND 1221359-2021-03646 FOR RELATED UNCONFIRMED FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED (6) SIX UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2021 USING THREE DIFFERENT LOTS (LOT M163076, LOT M163379 AND LOT 1047041). THE (6) SIX UNCONFIRMED FALSE POSITIVES WILL REPORTED BETWEEN (5) FIVE REPORTS. THIS MFR. REPORT ADDRESSES REPORT 4 OF 6 USING LOT 1047041. THE CUSTOMER REPORTED (1) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 (10:31AM) ON A DIRECT TESTED NASAL KITTED SWAB SAMPLE. THE CUSTOMER REPORTED TESTS WERE NOT REPEATED FOR PATIENTS AND PCR CONFIRMATORY TESTING WAS NOT PERFORMED. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC (6) SIX DAYS AND HAD BEEN COVID EXPOSURE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805397 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1047041 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown