BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12889091 · Received November 30, 2021

    Report

    Report Number
    1221359-2021-03458
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    October 25, 2021
    Report Date
    April 12, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M160774 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 M160774 AND TEST BASE PART NUMBER 190-430 / LOT M160774. 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 M160774 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 PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR NUMBERS: 1221359-2021-03456, 1221359-2021-03457.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT 3 OF 3. THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 AT 15:30 ON A DIRECT TESTED NASOPHARYNGEAL KITTED SWAB. REPEAT TESTING WAS PERFORMED ON THE SAME DAY (B)(6) 2021 AT 15:45 GENERATING NEGATIVE RESULTS. ONE ADDITIONAL REPEAT TEST WAS ALSO PERFORMED ON THE SAME DAY AT 16:01 GENERATING NEGATIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791666 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC M160774 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown