BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 12140078 · Received July 8, 2021

    Report

    Report Number
    1221359-2021-01951
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    April 30, 2021
    Report Date
    August 17, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. MFR:REPORT: 1221359-2021-01927.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1023941 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 1023941, TEST BASE PART NUMBER 190-430 / LOT 1023941. 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 1023941 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE OR CROSS CONTAMINATION. REFERENCE MFR:REPORT: 1221359-2021-01927.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED 5 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021. THIS MFR. REPORT ADDRESSES THE EVENTS ON (B)(6) 2021 AND IS TWO (2) OF TWO (2). THE CUSTOMER REPORTED ONE (1) FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON DIRECT TESTED NASOPHARYNGEAL KITTED SWABS. REPEAT TEST WAS NOT PERFORMED, PCR CONFIRMATION TEST GENERATED NEGATIVE RESULT (PLATFORM UNKNOWN). THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC. 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
    1034636 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1023941 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1