BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14044921 · Received April 7, 2022

    Report

    Report Number
    1221359-2022-01675
    Event Type
    Malfunction
    Date Received
    April 7, 2022
    Report Date
    May 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS . A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-01673 THROUGH 1221359-2022-01676.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1061997 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 1061997, TEST BASE PART NUMBER 190-430 / LOT 1061997.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 1061997 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 ROOT CAUSE IS CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON A DIRECT TESTED NASAL KITTED SWAB. REPEAT TESTING WAS NOT .CONFIRMATION WITH PCR TESTING ON A NASOPHARYNGEAL SWAB GENERATED A NEGATIVE RESULT. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. NO ADDITIONAL PATIENT INFORMATION,INCLUDING TREATMENT,AND OUTCOME,WAS PROVIDED. THIS MFR. REPORT ADDRESSES TEST THREE OF FOUR LOT NUMBER (1061997) TOTAL (1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424253 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1061997 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown