BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11742923 · Received April 28, 2021

    Report

    Report Number
    1221359-2021-01326
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Report Date
    August 18, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE REPORTS: 1221359-2021-01306, 1221359-2021-01307, 1221359-2021-01308, 1221359-2021-01309, 1221359-2021-01310, 1221359-2021-01311, 1221359-2021-01312, 1221359-2021-01313, 1221359-2021-01314, 1221359-2021-01315, 1221359-2021-01316, 1221359-2021-01317, 1221359-2021-01318, 1221359-2021-01319, 1221359-2021-01320, 1221359-2021-01321, 1221359-2021-01322, 1221359-2021-01325. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1018201 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 1018201, TEST BASE PART NUMBER 190-430 / LOT 1018201. 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 1018201 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE OR CROSS CONTAMINATION. REFERENCE MFR:REPORT: 1221359-2021-01306, 1221359-2021-01307, 1221359-2021-01308, 1221359-2021-01309, 1221359-2021-01310, 1221359-2021-01311, 1221359-2021-01312, 1221359-2021-01313, 1221359-2021-01314, 1221359-2021-01315, 1221359-2021-01316, 1221359-2021-01317, 1221359-2021-01318, 1221359-2021-01319, 1221359-2021-01320, 1221359-2021-01321, 1221359-2021-01322, 1221359-2021-01325.

    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. HOWEVER, AT THE TIME OF THE REPORT, LOT # RELATIONSHIPS TO THE EVENTS WAS NOT KNOWN. THIS REPORT ADDRESSES EVENT NINETEEN (19) OF NINETEEN (19). ADDITIONALLY, THE 3 LOT #S ARE BEING REPORTED UNDER INDIVIDUAL MFR.REFERENCE #S. THE CUSTOMER REPORTED TWENTY SIX (26) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED FROM (B)(6) 2021 THROUGH (B)(6) 2021 ON A DIRECT TESTED COPAN, FLOQS SWAB (DRY SWABS)SWABS. DURING THIS TIME FRAME, IT WAS FOUND THROUGH LOGFILE REVIEW THAT ID NOW COVID-19 ASSAY LOT NUMBER 1013549 WAS USED. IT IS UNKNOWN WHICH DATES OR PATIENTS USED THIS LOT NUMBER. REPEAT TESTING WAS PERFORMED FOR SOME PATIENTS. CONFIRMATION TESTING WAS PERFORMED WITH THERMOFISHER, ARGENE, AND GENEXPERT PCR PLATFORMS AND GENERATED NEGATIVE RESULTS; CT VALUES NOT PROVIDED. NO ADDITIONAL IDENTIFYING PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 1

    THIS MFR. REPORT ADDRESSES LOT 1013549 AS AT THE TIME OF THE INITIAL REPORT LOT # RELATIONSHIPS TO THE EVENTS WERE NOT KNOWN. THIS INFORMATION HAS SINCE BEEN PROVIDED AND IS NOW REFLECTED IN MFR. REFERENCE #S (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632445 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1018201

    Patients

    Seq Age Sex Outcome Treatment
    1