BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15036645 · Received July 17, 2022

    Report

    Report Number
    1221359-2022-03616
    Event Type
    Malfunction
    Date Received
    July 17, 2022
    Date of Event
    June 16, 2022
    Report Date
    August 24, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE ALL RELATED MFR. REPORT NUMBERS: 1221359-2022-03385 & 1221359-2022-03615 THROUGH 1221359-2022-03618.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION TO THE PREVIOUSLY REPORTED EVENT. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063770 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 1063770 AND TEST BASE PART NUMBER 190-430 / LOT 1063770. 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 1063770 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 CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FIVE (5) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES PATIENT RESULT THREE (3) OF FIVE (5). THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE PATIENT RESULT WITH THE ID NOW COVID-19 ASSY PERFORMED ON (B)(6) 2022 WHICH GENERATED A POSTIVE RESULT. REPEAT TESTING WAS PERFORMED ON (B)(6) 2022 USING A BINAX NOW SELF TEST AND GENERATED A NEGATIVE RESULT. RETESTING WAS PERFORMED ON THE SAME DAY, AFTER A HARD REBOOT ON THE ID NOW INSTRUMENT, USING THE ID NOW COVID-19 ASSAY AND IT GENERATED A NEGATIVE RESULT. 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
    897294 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063770 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown