BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11676106 · Received April 15, 2021

    Report

    Report Number
    1221359-2021-00978
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4) INC. ON RETAINED KIT LOT 1022441 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 1022441, TEST BASE PART NUMBER 190-430 / LOT 1022441. 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 1022441 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER IT COULD BE RELATED TO THE SPECIFIC PATIENT SAMPLES.

    Additional Manufacturer Narrative · 1

    REFERENCE REPORTS: 1221259-2021-00977. THE INVESTIGATION IS STILL 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 PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES EVENTS TWO (2) OF TWO (2). THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON AN UNKNOWN SAMPLE TYPES WITH A COPAN BRAND SWABS IN VIRAL TRANSPORT MEDIA. IT IS UNKNOWN IF REPEAT TESTING WAS PERFORMED. CONFIRMATION TESTING ON UNKNOWN SWABS WITH MOBIDIAG GENERATED POSITIVE RESULTS; CT VALUES NOT PROVIDED. TWO PATIENTS WERE POSITIVE FOR THE (B)(6) VARIANT OF COVID-19 (WHICH PATIENT IS UNCONFIRMED). THE CUSTOMER STATED THE PATIENTS WERE SYMPTOMATIC. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566548 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1022441

    Patients

    Seq Age Sex Outcome Treatment
    1