BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ID NOW COVID-19

    MDR report key: 11722688 · Received April 26, 2021

    Report

    Report Number
    1221359-2021-01237
    Event Type
    Injury
    Date Received
    April 26, 2021
    Report Date
    July 23, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION; INVESTIGATION TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M130193 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 ART NUMBER 190-000 / LOT M130193 AND TEST BASE PART NUMBER 190-430 / LOT M130193. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS INVALID PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M130193 SHOWED THAT THE COMPLAINT RATE IS 0.01%. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. FILE ATTACHMENTS NO FILES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE INVALID TEST. AS A RESULT OF INVALID TEST ONE (1) PATIENT'S SURGERY WAS DELAYED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625633 ID NOW COVID-19 ID NOW COVID-19 ASSAY QJR ABBOTT DIAGNOSTICS SCABOROUGH, INC. M130193 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1