BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11203466 · Received January 20, 2021

    Report

    Report Number
    1221359-2021-00105
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 31, 2020
    Report Date
    February 22, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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 SAMPLE. 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 CORRECTED DATA: TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 1

    MANUFACTURING DOCUMENT REVIEW: THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR KIT PART NUMBER 190-000/ LOT 1012632 AND TEST BASE PART NUMBER 190-430/ LOT 1012632. ONE FALSE POSITIVE RESULT WAS OBSERVED DURING QUALITY CONTROL RELEASE TESTING WHICH IS ACCEPTABLE UNDER RELEASE SPECIFICATIONS. LOT TRACE: THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS (B)(4). NO FURTHER ACTION IS REQUIRED. RETAIN TESTING: TESTED THE ID NOW COVID-19 RETAIN TEST KIT LOT 1012632 WITH COVID-19 LOD AND A BLANK PATIENT SWAB ELUTED IN ELUTION BUFFER. ALL TESTS WERE RUN IN DUPLICATE, WERE VALID AND PERFORMED AS EXPECTED. NO UNEXPECTED OR FALSE POSITIVE RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2020 ON A DIRECT TESTED NASAL KITTED SWAB. THE MEDICAL TECHNICIAN SWABBED BILATERAL NOSTRILS AND STORED THE SAMPLE AT ROOM TEMPERATURE FOR 30 MINUTES BEFORE TESTING. THE NASAL SWAB WAS USED PER THE PRODUCT INSERT INSTRUCTIONS. FOUR-SIX HOURS LATER, CONFIRMATION PCR TESTING WAS PERFORMED TWO MORE TIMES ON AN UNKNOWN PLATFORM WITH A NEGATIVE RESULT. (CT VALUES NOT PROVIDED). REPEAT TESTING ON THE ID NOW COVID-19 ASSAY WAS PERFORMED WITH A NEW SAMPLE 2 DAYS LATER PRODUCING A NEGATIVE RESULT. 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. THE PATIENT WAS QUARANTINED. 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
    100705 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1012632 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR