BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11699355 · Received April 21, 2021

    Report

    Report Number
    1221359-2021-01180
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 17, 2021
    Report Date
    July 22, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION/CORRECTED DATA: B3: AFTER FURTHER REVIEW OF THE CASE, IT WAS DETERMINED THIS EVENT OCCURRED ON 17MAR2021. H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1023350 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: 1023350 , TEST BASE PART NUMBER 190-430 / LOT: 1023350 . 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 1023350 SHOWED THAT THE COMPLAINT RATE IS (B)(4). 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4(UDI). ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER IDENTIFIED THAT BOTH A DIRECT SAMPLE AND SAMPLE IN VIRAL TRANSPORT MEDIUM (VTM) WERE COLLECTED FOR THE PATIENT'S TESTING. CORRECTED DATA: B3.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE WITH ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 USING A DIRECT TESTED NASAL SWAB. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION PCR TESTING ON A NASOPHARYNGEAL SWAB USING RHEONIX PLATFORM WAS PERFORMED ON (B)(6) 2021 AND GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THAT THE PATIENT WAS SYMPTOMATIC. THE CUSTOMER CONFIRMED NO PATIENT HARM OCCURRED AND THERE WAS NO IMPACT TO TREATMENT ALTHOUGH THERE WAS A DELAY (UNSPECIFIED). PER THE CUSTOMER, THIS EVENT INVOLVED A NURSING HOME PATIENT, "THINKING IT WAS A VARIANT, WAS SENT TO STATE. THEY RAN PCR AND IT WAS "NOT DETECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602241 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC 1023350

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR