BEUDAMED
    FDA Adverse Event Death Summary report: N

    ID NOW COVID-19

    MDR report key: 10077646 · Received May 20, 2020

    Report

    Report Number
    1221359-2020-00064
    Event Type
    Death
    Date Received
    May 20, 2020
    Date of Event
    April 19, 2020
    Report Date
    May 20, 2020
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(6), INC. ON RETAINED KIT LOT M118672 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 M118672 AND TEST BASE PART NUMBER 190-430 / LOT M118672 WERE REVIEWED. THIS 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 M118672 SHOWED THAT THE COMPLAINT RATE IS (B)(4). THE EVIDENCE AVAILABLE DOES NOT INDICATE THAT THE PRODUCT IS PERFORMING OUTSIDE LABEL CLAIMS. ABBOTT DIAGNOSTICS SCARBOROUGH, 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

    A CUSTOMER SENT A CUMULATIVE REPORT OF TEN (10) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS SEVEN (7) DIFFERENT TESTING SITES. THIS REPORT REPRESENTS SEVEN (7) OF TEN (10). A CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH A DIRECT NASAL SWAB SAMPLE (SWAB TYPE NOT OTHERWISE SPECIFIED) ON THE ID NOW COVID-19 ASSAY. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2020; TESTING DATE AND TIME IS UNKNOWN. ADDITIONAL TESTING ON A NASOPHARYNGEAL (NP) SWAB ELUTED IN VTM (SWAB AND VTM TYPE NOT OTHERWISE SPECIFIED) WAS POSITIVE BY CORE LAB. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2020; TESTING DATE AND TIME IS UNKNOWN. ON 15 MAY 2020, THE CUSTOMER REPORTED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2020. INFORMATION REGARDING WHETHER THE ID NOW COVID-19 ASSAY CONTRIBUTED TO THE PATIENT'S EXPIRY IS CURRENTLY UNKNOWN. ADDITIONAL INFORMATION, INCLUDING SYMPTOMS, TREATMENT AND OFFICIAL CAUSE OF DEATH IS CURRENTLY UNAVAILABLE. A REQUEST TO COLLECT ALL UNKNOWN INFORMATION FROM THE CUSTOMER WAS SUBMITTED 16 MAY 2020. A RESPONSE FROM THE CUSTOMER WAS RECEIVED 19 MAY 2020, STATING THAT THE CUSTOMER "CANNOT AND WILL NOT SPECULATE ON THIS. THAT DETERMINATION NEEDS TO BE MADE BY THE PHYSICIANS AND STAFF WHO ACTUALLY TREATED THE PATIENT." A REQUEST TO OBTAIN APPROPRIATE CONTACT INFORMATION IN AN EFFORT TO GAIN FURTHER PATIENT INFORMATION WAS REQUESTED 19 MAY 2020. ON 20 MAY 2020, THE CUSTOMER RESPONDED, STATING: "IF THE ID NOW REPORTS NEGATIVE RESULTS THE FACILITIES RUN PCR WITHIN 24 HOURS AND IF IT RESULTS POSITIVE THEY IMMEDIATELY TAKE ACTION." THE CUSTOMER ALSO PROVIDED THE REQUESTED CONTACT INFORMATION. A COMMUNICATION ATTEMPT WITH THE RESPECTIVE CONTACT WAS MADE 20 MAY 2020 AND A REQUEST FOR RESPONSE WAS MADE THROUGH VOICEMAIL. ANY ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER AND/OR APPROPRIATE CONTACT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT TO THE FDA. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS DO NOT PRECLUDE SARS-COV-2 INFECTION AND SHOULD NOT BE USED AS THE SOLE BASIS FOR PATIENT MANAGEMENT DECISIONS. NEGATIVE RESULTS MUST BE COMBINED WITH CLINICAL OBSERVATIONS, PATIENT HISTORY, AND EPIDEMIOLOGICAL INFORMATION. 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 POTENTIAL FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE AS AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539561 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M118672 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Death