BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11781483 · Received May 5, 2021

    Report

    Report Number
    1221359-2021-01421
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 4, 2021
    Report Date
    October 6, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H10: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1017891 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: 1017891 , TEST BASE PART NUMBER 190-430 / LOT: 1017891 . 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 1017891 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FASLE POSITIVE RESULT ON A DIRECT NASOPHARYNGEAL SWAB (IMPROSWAB MICROBIOLOGICAL TRANSPORT SWAB) WHILE USING THE ID NOW COVID-19 ASSAY ON (B)(6) 2021. NO REPEAT TESTING TOOK PLACE. PCR CONFIRMATION TESTING THE SAME DAY ON A NASOPHARYNGEAL SWAB IN MTU MEDIUM GENERATED NEGATIVE RESULTS. THE CUSTOMER CONFIRMED THE PATIENT WAS ASYMPTOMATIC. THE PATIENT UNDERWENT SURGERY FOR APPENDICITIS. PER THE CUSTOMER THERE WAS NO PATIENT HARM DUE TO THE TEST RESULT. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674779 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1017891 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1