BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14145176 · Received April 19, 2022

    Report

    Report Number
    1221359-2022-01845
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON HOLD MR 08/30/2022. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 190-000 J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. REFERENCE MFR. REPORTS: 1221359-2022-01843.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M180337 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 190-000J / LOT M180337 , TEST BASE PART NUMBER 190-430 / LOT M180337.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 M180337 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. MFR. REPORTS: 1221359-2022-01843 THROUGH 1221359-2022-01845.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A PATIENT HAD A NEGATIVE RESULT WITH A DENKA COVID 19 ANTIGEN TEST ON (B)(6) 2022, THEN PROCEEDED TO HAVE 1 FALSE POSITIVE RESULT ON (B)(6) 2022 AND 2 FALSE POSITIVES ON (B)(6) 2022 WITH THE ID NOW COVID-19 ASSAY USING NASOPHARYNGEAL SWABS. THE FIRST PCR TEST WAS PERFORMED ON (B)(6) 2022 AND THE SECOND PCR TEST WAS PERFORMED ON (B)(6) 2022, BOTH WITH NEGATIVE RESULTS USING NASOPHARYNGEAL SWABS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THIS MFR. REPORT ADDRESSES TEST ONE (1) OF THREE (3) TESTS LOT NUMBER (M180337) TOTAL (2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867855 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M180337 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown