BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11305404 · Received February 9, 2021

    Report

    Report Number
    1221359-2021-00298
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 9, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO SPECIFIC PATIENT SAMPLE, CROSS CONTAMINATION, OR ENVIRONMENTAL CONTAMINATION.

    Additional Manufacturer Narrative · 1

    REFER TO MRN: 1221359-2021-00268. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1009632 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT 1009632 AND TEST BASE PART NUMBER 190-430 / LOT 1009632 WERE REVIEWED. THIS LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS AND FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1009632 SHOWED THAT THE COMPLAINT RATES ARE (B)(4) AND (B)(4), RESPECTIVELY. ABBOTT DIAGNOSTICS (B)(4), INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. 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 THERE WERE MORE THAN FIVE (5) CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY. THIS REPORT REPRESENTS THE OUTCOMES OF THREE (3) OF THE FIVE (5) PATIENTS. THIS IS REPORT TWO (2) OF TWO (2). THE CUSTOMER REPORTED THAT POSITIVE RESULTS WERE OBTAINED WITH ID NOW COVID-19 ASSAY (S/N (B)(4)) PERFORMED (B)(6) 2021 FOR MORE THAN FIVE (5) PATIENTS. REPEAT TESTING WITH THE ID NOW COVID-19 ASSAY (S/N (B)(4) ) GENERATED NEGATIVE RESULTS. THE CUSTOMER SUSPECTED CONTAMINATION. AFTER FOLLOWING CLEANING PROCEDURES PER PACKAGE INSERT AND CONTROLS RETURNED EXPECTED RESULTS, REPEAT TESTING WITH THE ID NOW COVID-19 ASSAY (S/N (B)(4) ) GENERATED NEGATIVE RESULTS. SWAB TYPE, SAMPLE TYPE AND USE OF VIRAL TRANSPORT MEDIA WERE NOT PROVIDED. THE CUSTOMER REPORTED THAT COVID-19 TESTS ARE MANDATORY AT THIS HOSPITAL FOR EVERY PATIENT. THREE (3) OF THE PATIENTS WERE ASYMPTOMATIC AND TWO (2) PATIENTS HAD A COUGH AT THE TIME OF TESTING. THE PATIENTS WERE QUARANTINED FOR 48 HOURS, FROM (B)(6) 2021 TO (B)(6) 2021, AFTER THE POSITIVE ID NOW COVID-19 ASSAY RESULTS. TWO (2) OF THE PATIENTS WERE HOSPITALIZED FOR A BROKEN LEG, AND THEIR SURGERIES WERE POSTPONED UNTIL (B)(6) 2021. NO MEDICAL TREATMENT WAS PROVIDED DUE TO THE TEST RESULTS. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: 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. NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND, IF INCONSISTENT WITH CLINICAL SIGNS AND SYMPTOMS OR NECESSARY FOR PATIENT MANAGEMENT, SHOULD BE TESTED WITH DIFFERENT AUTHORIZED OR CLEARED MOLECULAR TESTS. NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS SHOULD BE CONSIDERED IN THE CONTEXT OF A PATIENT'S RECENT EXPOSURES, HISTORY AND THE PRESENCE OF CLINICAL SIGNS AND SYMPTOMS CONSISTENT WITH COVID-19. UNEXPLAINED CONFLICTING RESULTS SHALL BE REPORTED AS IT IS UNKNOWN WHICH RESULT IS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201563 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1009632 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1