BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAX NOW COVID-19 AG CARD

    MDR report key: 11316759 · Received February 11, 2021

    Report

    Report Number
    1221359-2021-00277
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 11, 2021
    Report Date
    November 14, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA202537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED FOR 2 OF THE FALSE POSITIVES AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. NOTWITHSTANDING, A REVIEW OF COMPLAINTS' TREND REVEALS THAT ALL LOTS WITHIN EXPIRY DATING ARE PERFORMING ACCORDING TO THE STATEMENTS MADE IN THE PACKAGE INSERT. IN CONCLUSION,ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1013538 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: 1013538, TEST BASE PART NUMBER 190-430 / LOT: 1013538. 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 1013538 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE ISSUE AS THE LOGFILES WERE NOT PROVIDED. HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    ALTHOUGH, THE INVESTIGATION IS STILL IN PROGRESS, TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 133348 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 133348 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER COMPLETION. PATIENT WEIGHT: (B)(6). PLEASE SEE RELATED MFR REPORT #S:(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER SENT A CUMULATIVE REPORT OF THREE FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS PATIENT THREE OF THREE. THE CUSTOMER REPORTED A POSITIVE RESULT FROM A DIRECT KITTED NASAL SWAB OF BOTH NOSTRILS WITH THE BINAXNOW COVID-19 AG CARD ASSAY PERFORMED ON THE MORNING OF (B)(6) 2021. PCR CONFIRMATION TESTING FROM A NASAL SAMPLE PERFORMED ON (B)(6) 2021 (PLATFORM NOT SPECIFIED) GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE PATIENT HAD PRE-EXISTING MEDICAL CONDITIONS (LETHARGIC, HAD ALTERED LOC AND WAS DIAPHORETIC) THAT WARRANTED SUPPORTIVE CARE PRIOR TO BEING TRANSFERRED TO THE COVID-19 UNIT. ON (B)(6) 2021, THE PATIENT WAS MOVED TO COVID-19 UNIT, PLACED ON COMFORT MEASURES AND SUBSEQUENTLY DIED OF AN UNKNOWN CAUSE. THE CUSTOMER CONFIRMED THAT THEY DID NOT BELIEVE THIS DEATH WAS DUE TO THE FALSE POSITIVE RESULT. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212706 BINAX NOW COVID-19 AG CARD LATERAL FLOW IMMUNOASSAY IVD OF COVID-19 QKP ABBOTT DIAGNOSTICS SCARBOROUGH INC. 1013538

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male