BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14141193 · Received April 19, 2022

    Report

    Report Number
    1221359-2022-01897
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 24, 2022
    Report Date
    May 4, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SIMILAR PRODUCT TO 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M177856 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 KIT PART NUMBER 191-000 / LOT M177856 AND TEST BASE PART NUMBER 190-430 / LOT M177856. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON A DIRECT TESTED KITTED NASAL SWAB ON (B)(6) 2022. CONFIRMATION PCR TESTING (PLATFORM: PANTHER PCR) WAS PERFORMED ON A NASOPHARANGEAL SAMPLE ON (B)(6) 2022 WHICH GENERATED A NEGATIVE RESULT. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC. NO FURTHER INFORMATION REGARDING HEALTH IMPACT OR OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867605 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M177856 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown