BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 12221822 · Received July 23, 2021

    Report

    Report Number
    1221359-2021-02109
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    June 25, 2021
    Report Date
    November 13, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA: H10. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1022562 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 191-000 / LOT: 1022562, TEST BASE PART NUMBER 190-430 / LOT: 1022562. 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 1022562 SHOWED THAT THE COMPLAINT RATE IS 0.03% ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. MFR REFERENCE REPORTS: 1221359-2021-02110.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORT: 1221359-2021-02110.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO (2) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 FOR TWO PATIENTS PERFORMED ON (B)(6) 2021 AND (B)(6) 2021 RESPECTIVELY. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO ( 2). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A SWAB (GONG DONG G1022FN). PCR CONFIRMATION TESTING GENERATED A NEGATIVE RESULT (PLATFORM: APTIMA, PANTHER, HOLOGIC). CUSTOMER CONFIRMED THAT THE PATIENT IS LIVING IN NURSING HOME AND RECEIVED TWO DOSES OF COVID-19 VACCINE. CUSTOMER CONFIRMED PATIENT IS UNDER ANTICOAGULANT THERAPY. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC FOR COVID-19 BUT HAS SYMPTOMS FOR COGNITIVE DISORDERS. PATIENT HAS HOSPITALIZED FOR 6 DAYS DUE TO SUSPECTED STROKE,COVID DIVISION AND RETURNED BACK TO NURSING HOME. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119198 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022562 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Female