BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14191091 · Received April 23, 2022

    Report

    Report Number
    1221359-2022-02265
    Event Type
    Malfunction
    Date Received
    April 23, 2022
    Date of Event
    March 19, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY UPDATED WITH NEW LOT TRACE PERCENTAGE: THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR KIT LOT M173879 BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS (B)(4).

    Additional Manufacturer Narrative · 0

    TESTED THE ID NOW COVID-19 RETAIN TEST KIT LOT M173879 WITH COVID-19 LOD AND A BLANK PATIENT SWAB ELUTED IN ELUTION BUFFER. ALL TESTS WERE RUN IN DUPLICATE, WERE VALID, AND PERFORMED AS EXPECTED. NO FALSE NEGATIVE RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR KIT PART NUMBER 191-000 / LOT M173879 AND TEST BASE PART NUMBER 190-430 / LOT M173879. QUALITY CONTROL RELEASE TESTING MET SPECIFICATIONS WITH NO FALSE NEGATIVE RESULTS OBSERVED. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS 0.005%. BASED ON THE EVIDENCE AVAILABLE, IT INDICATES THAT THE LOT PERFORMING AS INDICATED IN THE LABEL STATEMENTS. NO FURTHER ACTION IS REQUIRED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2022. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689906 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M173879 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown