BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14239961 · Received April 28, 2022

    Report

    Report Number
    1221359-2022-02136
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 1, 2022
    Report Date
    June 3, 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
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-02141.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M180456 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 M180456, TEST BASE PART NUMBER 190-000 / LOT M180456. 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 M180456 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. H10 : REFERENCE MFR. REPORTS:1221359-2022-02136 THROUGH 1221359-2022-02141.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIX (6) FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022 ON MIDTURBINATE NASAL .CONFORMATION TEST (PCR), WAS PERFORMED ON (B)(6) 2022, NASOPHARYNGEAL SWABS, AND GENERATED NEGATIVE RESULT. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS A DELAY ON STAFF TESTED POSITIVE, MISSED WORK, WERE FOUND NEGATIVE THROUGH PCR TESTING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME,WAS PROVIDED. THIS REPORT IS ONE (1) OF SIX (6) AND ADDRESSES LOT (M180456) TOTAL QUANTITY (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105847 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M180456 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female