BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13046437 · Received December 20, 2021

    Report

    Report Number
    1221359-2021-03754
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Report Date
    January 20, 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
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR. REPORT: 1221359-2021-03750, 1221359-2021-03751, 1221359-2021-03752, 1221359-2021-03753.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M163541 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: M163541, TEST BASE PART NUMBER 190-430 / LOT: M163541. 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 M163541 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED WITH M159961 AND M163541 LOT NUMBERS. THIS MFR. REPORT ADDRESSES PATIENT FIVE (5) OF FIVE (5). THERE IS NO INDICATION ON WHICH LOT WAS USED WITH THIS PATIENT. WHILE M163541 IS LISTED IN THIS REPORT, INVESTIGATION WILL BE CONDUCTED ON BOTH LOTS. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON A DIRECTLY TESTED NASAL SWAB WITH THE ID NOW COVID-19 ASSAY. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). PER THE CUSTOMER, THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THERE WAS NO DELAY OR IMPACT IN TREATMENT DUE TO TEST RESULTS. THE PATIENT WAS NOT SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945908 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M163541 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown