BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11255583 · Received January 29, 2021

    Report

    Report Number
    1221359-2021-00087
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Report Date
    February 26, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1012795 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 1012795 AND TEST BASE PART NUMBER 190-430/ LOT 1012795. 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 1012795 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MANUFACTURER REPORTS: 1221359-2021-00067, 1221359-2021-00068, 1221359-2021-00069, 1221359-2021-00086, 1221359-2021-00088, 1221359-2021-00089, 1221359-2021-00138, 1221359-2021-00139, 1221359-2021-00140, 1221359-2021-00141.

    Additional Manufacturer Narrative · 1

    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 OR CROSS CONTAMINATION. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS. THIS MFR. REPORT ADDRESSES LOT 5 OF 11. THERE WERE 2 PATIENT FALSE POSITIVES ASSOCIATED WITH THIS LOT WITH A TESTING DATE OF (B)(6) 2020. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON A DIRECT TESTED NASOPHARYNGEAL KITTED SWAB. IT INVOLVED 15 ID NOW INSTRUMENTS. CUSTOMER STATED THEY SUSPECTED SOMETHING WAS NOT WORKING PROPERLY AS THEY HAD A LARGE AMOUNT OF POSITIVE RESULTS AND SO THEY STARTED RUNNING TWO SAMPLES ON DIFFERENT ID NOW'S FOR EACH PATIENT SAMPLE. THE NASOPHARYNGEAL SWAB WAS USED TO SWAB BOTH NOSTRILS PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS PERFORMED. NEW SAMPLE COLLECTED ON A NEW SAMPLE RECEIVER. RESULT OF THE REPEAT TESTS WERE POSITIVE. CONFIRMATION TESTING WAS PERFORMED USING PCR AND GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE CUSTOMER REPORTED THE PATIENTS EXPERIENCED PSYCHOLOGICAL DAMAGE DUE TO MISDIAGNOSIS OR FEAR OF INFECTING OTHERS, ISOLATION, OR STIGMATIZATION. PER THE CUSTOMER, INACCURATE RESULTS CAUSE UNNECESSARY TREATMENT CANCELLATION OR POSTPONEMENT. 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
    147145 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1012795

    Patients

    Seq Age Sex Outcome Treatment
    1