BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14470811 · Received May 23, 2022

    Report

    Report Number
    1221359-2022-02711
    Event Type
    Malfunction
    Date Received
    May 23, 2022
    Report Date
    June 10, 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
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. RELATED MFR. REPORT NUMBER: 1221359-2022-02710.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1060972 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 1060972 AND TEST BASE PART NUMBER 190-430 / LOT 1060972. 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 1060972 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, IT COULD POSSIBLY BE RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. RELATED MFR. REPORT NUMBER: 1221359-2022-02710.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON UNKNOWN SAMPLE TYPES ON AN UNKNOWN DATE. THIS REPORT IS FOR PATIENT TWO OF TWO. THE PATIENT HAD CONFIRMATORY PCR TESTING PERFORMED IMMEDIATELY AFTER RECEIVING THE POSITIVE RESULT WITH THE ID NOW WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT THE PATIENT WAS ASYMPTOMATIC. ALTHOUGH REQUESTED, NO FURTHER INFORMATION REGARDING PATIENT HEALTH STATUS AND OUTCOME WAS PROVIDED. IT WAS NOTED THAT THE CUSTOMER IS NOT CLEANING THE INSTRUMENT REGULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551778 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1060972 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown