BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11859761 · Received May 20, 2021

    Report

    Report Number
    1221359-2021-01535
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 12, 2021
    Report Date
    December 21, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED ON RETAIN KIT LOT 1023225 WITH THE ABBOTT DIAGNOSTICS SCARBOROUGH'S LIMIT OF DETECTION (LOD) POSITIVE QUALITY CONTROL X2 DEVICES AND NEGATIVE CONTROL SWABS X2 DEVICES. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING AND QUALITY CONTROL RELEASE TESTING WERE REVIEWED FOR TEST BASE LOT 1023225 AND THEY MET RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1023225 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Additional Manufacturer Narrative · 1

    REFERENCE MFR. REPORT: 1221359-2021-01531 (PATIENT 1), 1221359-2021-01532 ( PATIENT 2), 1221359-2021-01533 (PATIENT 3), 1221359-2021-01534 ( PATIENT 4), 1221359-2021-01536 ( PATIENT 6), 1221359-2021-01537 ( PATIENT 7). THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES . THIS MFR. REPORT ADDRESSES PATIENT FIVE (5) OF SEVEN ( 7) . THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL KITTED SWAB. REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING ON NASOPHARYNGEAL SWABS WITH CEPHIED PLATFORM GENERATED NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS NOT SYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750314 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1023225

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male