BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12604583 · Received October 11, 2021

    Report

    Report Number
    1221359-2021-03111
    Event Type
    Malfunction
    Date Received
    October 11, 2021
    Date of Event
    September 11, 2021
    Report Date
    December 15, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATES: SECTION B5: ADDITIONAL INFORMATION REGARDING EVENT ADDED. PATIENT 2 TESTED ONE TIME ON THIS LOT. SECTION B6: DATE OF EVENT ADDED. H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1030370 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST BASE LOT 1030370. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING), RELATED TO KIT LOT 1030370 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 SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. PLEASE REFERENCE RELATED MFR. REPORT NUMBER 1221359-2021-03110 FOR PATIENT 1/LOT 1 AND 1221359-2021-03478 FOR PATIENT 3/LOT 3.

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MFR. REPORT NUMBER: 1221359-2021-03110. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. CONFIRMATION TESTING ON NASAL SWABS WITH THE APTIMA COLLECTION SYSTEM GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED) CUSTOMER STATES EMPLOYEE WAS ALLOWED TO RETURN TO WORK BASED ON THE INITIAL FALSE NEGATIVE RESULT OBTAINED ON THE ID NOW COVID-19 ASSAY. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. CUSTOMER REPORTED A TOTAL OF FIVE FALSE NEGATIVE RESULTS ON THREE PATIENTS AND THREE LOTS. THIS REPORT ADDRESSES PATIENT 2 TESTED ON LOT 2 OF 3.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS ACROSS TWO LOTS. THIS MFR. REPORT ADDRESSES LOT 2 OF 2. THE CUSTOMER REPORTED FIVE FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19. IT WAS NOT SPECIFIED THE NUMBER OF PATIENTS THAT TESTED ON EACH LOT NUMBER. REPEAT TESTING WAS NOT PERFORMED. CONFORMATION TESTING GENERATED POSITIVE RESULTS (CT VALUES NOT PROVIDED). THE CUSTOMER STATED ALL FIVE PATIENTS WERE SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508344 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1030370 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown