BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11936607 · Received June 3, 2021

    Report

    Report Number
    1221359-2021-01655
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Report Date
    August 10, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    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 1023594 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 1023594, TEST BASE PART NUMBER 190-430 / LOT 1023594. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVES RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1023594 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 AS THE LOGFILES PROVIDED WERE INACCESSIBLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFER TO MFR. REPORT NUMBERS: 1221359-2021-01652, 1221359-2021-01653, 1221359-2021-01654, 1221359-2021-01656 AND 1221359-2021-01657.

    Description of Event or Problem · 1

    THE CUSTOMER SENT A CUMULATIVE REPORT OF THIRTEEN (13) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS EIGHT (8) DIFFERENT TESTING SITES PERFORMED ON VARIES DATES. THIS MFR. REPORT ADDRESSES LOT 4 OF 6. THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THE NASAL SAMPLE WERE COLLECTED ON (B)(6) 2021 AND (B)(6) 2021. CONFIRMATION TESTING WAS PERFORMED BY CORELAB AND GENERATED POSITIVE RESULTS. NASOPHARYNGEAL SAMPLES IN TRANSPORT MEDIA WERE COLLECTED ON (B)(6) 2021. CORELAB PLATFORM WAS USED TO TEST ALL SAMPLES. PER THE CUSTOMER, NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832860 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1023594 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1