BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13497260 · Received February 9, 2022

    Report

    Report Number
    1221359-2022-00773
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 22, 2022
    Report Date
    March 7, 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
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1036134 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: 1036134, TEST BASE PART NUMBER 190-430 / LOT: 1036134. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1036134 SHOWED THAT THE COMPLAINT RATE IS (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 A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022 PERFORMED ON A NASOPHARYNGEAL (NP) SAMPLE USING A FLOQ SWAB. A NEW SAMPLE WAS IMMEDIATELY COLLECTED (NP) FOR CONFIRMATORY TESTING (BIOFIRE RTPCR- GENEXPERT PCR) WHICH RESULTED IN A NEGATIVE RESULT. THE CUSTOMER REPORTED THAT THE PATIENT PRESENTED WITH EXACERBATION OF SHORTNESS OR BREATH AND WAS HOSPITALIZED. THE CUSTOMER REPORTED THAT THE PATIENT WAS TREATED AS A COVID NEGATIVE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574588 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1036134 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown