BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11324085 · Received February 12, 2021

    Report

    Report Number
    1221359-2021-00282
    Event Type
    Malfunction
    Date Received
    February 12, 2021
    Date of Event
    January 9, 2021
    Report Date
    March 31, 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
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: REPORT 4 OF 9. PLEASE SEE RELATED MFR REPORT #S: 1221359-2021-00279, 1221359-2021-00286, & 1221359-2021-00864 (9). UPON INVESTIGATION COMPLETION AND LOGFILE REVIEW, IT WAS DETERMINED THAT LOT 1007882 WAS ALSO INVOLVED IN THE EVENT. ALTHOUGH REQUESTED CLARIFYING DETAILS HAVE NOT BEEN PROVIDED. 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

    ALTHOUGH THE INVESTIGATION IS STILL IN PROGRESS, TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1008951 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 10018951 AND TEST BASE PART NUMBER 190-430/LOT 1008951 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 1008951 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER COMPLETION. PLEASE SEE RELATED MFR REPORT #S: 1221359-2021-00279, 1221359-2021-00281, AND 1221359-2021-00283, 1221359-2021-00286.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEVENTEEN FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THE CUSTOMER PROVIDED SPECIFIC PATIENT INFORMATION FOR ONLY SEVEN (7) OF THESE FALSE NEGATIVES. THEREFORE, A TOTAL OF EIGHT (8) REPORTS WILL BE SUBMITTED, INCLUDING ONE (1) REPORT FOR THE REMAINING TEN (10) FALSE NEGATIVES. THIS REPORT REPRESENTS REPORT FOUR (4) OF EIGHT (8). THE CUSTOMER REPORTED A NEGATIVE RESULT ON A KITTED NASAL SWAB OF BOTH NOSTRILS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 AT 1:18PM. PCR CONFIRMATION TESTING PERFORMED ON (B)(6) 2021 AT (B)(6) WITH A NASOPHARYNGEAL SAMPLE GENERATED POSITIVE RESULTS WITH THE BIOFIRE RP2.1. THE PATIENT WAS REPORTED AS SYMPTOMATIC. NO ADDITIONAL INFORMATION, INCLUDING TREATMENT OR OUTCOME WAS PROVIDED. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY AND TREATMENT WAS NOT IMPACTED/DELAYED. THE ID NOW COVID-19 PRODUCT INSERT INDICATES THAT NEGATIVE RESULTS SHOULD BE TREATED AS PRESUMPTIVE AND TESTED WITH AN ALTERNATIVE FDA AUTHORIZED MOLECULAR ASSAY, IF NECESSARY FOR CLINICAL MANAGEMENT, INCLUDING INFECTION CONTROL. THE PI STATES 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 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
    220705 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH INC. 1008951 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1