BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11645865 · Received April 9, 2021

    Report

    Report Number
    1221359-2021-00360
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    September 18, 2020
    Report Date
    April 9, 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
    501

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT 1001941 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 1001941 AND TEST BASE PART NUMBER 190-430 / LOT 1001941. 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 1001941 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE;HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT/VALIDATION SAMPLES. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT. REFERENCE MANUFACTURER REPORTS: 1221359-2021-00352, 1221359-2021-00353, 1221359-2021-00354, 1221359-2021-00355, 1221359-2021-00356, 1221359-2021-00357, 1221359-2021-00358, 1221359-2021-00359, 1221359-2021-00368, AND 1221359-2021-00369.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS. THERE WERE 11 FALSE POSITIVE RESULT REPORTED. THIS MFR. REPORT ADDRESSES PATIENT 9 OF 11, TEST PERFORMED ON (B)(6) 2020 WITH LOT 1001941. THE CUSTOMER REPORTED THAT THE ID NOW COVID-19 ASSAY WAS PERFORMED ON A DIRECT TESTED KITTED NASOPHARYNGEAL SWABS. THE NASOPHARYNGEAL SWAB WAS USED TO SWAB BOTH NOSTRILS PER THE PRODUCT INSERT INSTRUCTIONS. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING USING NASOPHARYNGEAL SWABS WITH PCR GENERATED NEGATIVE RESULTS. CT VALUES NOT PROVIDED. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, HARM/DELAY/IMPACT WAS PROVIDED. 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
    542511 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1001941 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR