BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14495811 · Received May 25, 2022

    Report

    Report Number
    1221359-2022-02813
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    May 6, 2022
    Report Date
    June 14, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. THE FOLLOWING MFR REPORT NUMBERS ARE RELATED TO THIS REPORT: 1221359-2022-02811, 1221359-2022-02812, 1221359-2022-02814.

    Additional Manufacturer Narrative · 0

    TESTED THE ID NOW COVID-19 RETAIN TEST KIT LOT 1062338 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 UNEXPECTED OR FALSE POSITIVE RESULTS WERE OBSERVED, AND THE CUSTOMERS COMPLAINT WAS NOT REPLICATED. THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR KIT PART NUMBER 190-000 / LOT 1062338 AND TEST BASE PART NUMBER 190-430 / LOT 1062338. FOUR FALSE POSITIVES WERE OBSERVED DURING QC TESTING WHICH IS ACCEPTABLE PER SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR LOT 1062338 BASED ON THE TOTAL QUANTITY OF DEVICES MANUFACTURED FOR DISTRIBUTION IS 0.004% (2/53184). BASED ON THE EVIDENCE AVAILABLE, THE LOT IS PERFORMING AS EXPECTED. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE TESTS. THIS MFR. REPORT ADDRESSES TEST 3 OF 4. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED WITH A NASAL SAMPLE. PCR CONFIRMATION TESTING WAS PERFORMED AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2203155 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1062338 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown