BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11802417 · Received May 10, 2021

    Report

    Report Number
    1221359-2021-01448
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 5, 2021
    Report Date
    July 24, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    PMA / PMN Number
    EUA0000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE: 1221359-2021-001427.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1023031 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 1023031 AND TEST BASE PART NUMBER 190-430 / LOT 1023031. 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 M146382 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) 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 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES LOT TWI (2) OF TWO (2). THE CUSTOMER REPORTED CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON VARIOUS DATES ON DIRECT TESTED NASAL KITTED SWABS. THE CUSTOMER STATES THAT REPEAT TESTING WAS PERFORMED FOR SOME ON THE SAME ID NOW AND OTHERS ON A DIFFERENT ID NOW. THE CUSTOMER STATED THAT THEY HAVE DONE CONFIRMATION TESTING FOR 1 PATIENT POSITIVE (TESTED POSITIVE ON ID NOW ON (B)(6) 2021) AND NEGATIVE ON QUEST PCR TEST (B)(6) 2021. THE CUSTOMER STATED THE PATIENT WERE ASYMPTOMATIC. PER THE CUSTOMER NO TREATMENT WAS PROVIDED. 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
    696541 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH 1023034

    Patients

    Seq Age Sex Outcome Treatment
    1