BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11721490 · Received April 23, 2021

    Report

    Report Number
    1221359-2021-01241
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 25, 2021
    Report Date
    August 12, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO UPDATE THE MEDICAL DEVICE CODE, CORRECT B4 AND PROVIDE ADDITIONAL INFORMATION REGARDING THE RT-PCR TEST USED. ADDITIONAL INFORMATION: THE RT-PCR TEST USED IN THIS CASE WAS MANUFACTURED BY COBAS 4800. B4 AND H6 CORRECTION: THE INITIAL REPORT WAS SUBMITTED ON 4/23/2021.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE INVESTIGATION CONCLUSION AND ADDITIONAL INFORMATION. PLEASE UPDATES TO SECTION: G3, G6, H2 AND H6. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1022677 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 1022677 TEST BASE PART NUMBER 190-430 / LOT 1022677. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1022677 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, 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 · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSTDIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT 2 OF 3. THE CUSTOMER REPORTED ONE (1) FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASAL KITTED SWAB. THE NASAL USED TO SWAB BOTH NOSTRILS. REPEAT TESTING WAS NOT PERFORMED. RT-PCR CONFIRMATION TESTING WAS PERFORMED ON NASAL SWABS GENERATED NEGATIVE. THE CUSTOMER STATED THE PATIENT WAS SYMPTOMATIC. THE PATIENT WAS NOT TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617578 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022677

    Patients

    Seq Age Sex Outcome Treatment
    1