BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11499270 · Received March 16, 2021

    Report

    Report Number
    1221359-2021-00729
    Event Type
    Malfunction
    Date Received
    March 16, 2021
    Report Date
    July 8, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO MRN: 1221359-2021-00675, 1221359-2021-00676, 1221359-2021-00677, 1221359-2021-00730, 1221359-2021-00756. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M141384 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 M141384 AND TEST BASE PART NUMBER 190-430 / LOT M141384 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 M141384 SHOWED THAT THE COMPLAINT RATE IS (B)(4). INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE AN ASSIGNABLE ROOT CAUSE AS THE LOGFILES WERE NOT PROVIDED FOR INVESTIGATION, HOWEVER SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 1

    A CUSTOMER SENT A CUMULATIVE REPORT OF NINE FALSE NEGATIVE RESULTS INVOLVING SIX LOT NUMBERS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS SEVEN DIFFERENT TESTING SITES. THIS REPORT REPRESENTS LOT NUMBER M141384. THIS IS REPORT FOUR OF SIX. THE CUSTOMER REPORTED ONE FALSE NEGATIVE RESULTS USING A NASAL SWAB WITH THE ID NOW COVID-19 TEST. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2021; TESTING DATE AND TIME IS UNKNOWN. CONFIRMATION TESTING WAS PERFORMED ON A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA WITH (B)(6) LAB PROVIDED POSITIVE RESULTS. CONFIRMATORY SPECIMEN COLLECTION OCCURRED ON (B)(6) 2021. ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT AND OUTCOME, IS UNKNOWN. NO ADDITIONAL INFORMATION WILL BE PROVIDED. 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 POTENTIAL FALSE NEGATIVE RESULT LEADING TO NO OR DELAYED TREATMENT, THIS EVENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391974 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M141384 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1