BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11383114 · Received February 25, 2021

    Report

    Report Number
    1221359-2021-00579
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 14, 2021
    Report Date
    April 2, 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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 SAMPLES.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), 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 191-430/ LOT 1013538. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1013538 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER MENTIONED A CASE WHERE ANOTHER FALSE NEGATIVE RESULT WAS OBSERVED. FURTHER CLARIFICATION REGARDING THIS HAS NOT BEEN RECEIVED. AN ADDITIONAL REPORT WILL BE SUBMITTED IF FURTHER DETAILS ARE PROVIDED. THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON NASOPHARYNGEAL SWAB. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON AN UNKNOWN SWAB TYPE WITH PCR WAS DONE THREE (3) TIMES ON (B)(6) 2021. THE RESULTS OF CONFIRMATION TESTING ARE AS FOLLOWS: E-GENE PCR: POSITIVE; CT VALUE 30.96, N-GENE PCR: POSITIVE; CT VALUE 33.43, AND RDRP GENE PCR: POSITIVE; CT VALUE 32.46. THE CUSTOMER STATED THE PATIENT REQUIRED TESTING FOR COVID-19 PRIOR TO AN ORTHOPEDIC PROCEDURE. 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. 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. ADDITIONALLY, THE ID NOW COVID-19 PRODUCT INSERT INCLUDES A LIMITATION THAT FALSE NEGATIVE RESULTS MAY OCCUR IF A SPECIMEN IS IMPROPERLY COLLECTED, TRANSPORTED OR HANDLED. FALSE NEGATIVE RESULTS MAY ALSO OCCUR IF AMPLIFICATION INHIBITORS ARE PRESENT IN THE SPECIMEN OR IF INADEQUATE LEVELS OF VIRUSES ARE PRESENT IN THE SPECIMEN. DUE TO THE RISK OF A FALSE NEGATIVE RESULT POTENTIALLY LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274717 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013538 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR