BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12321588 · Received August 13, 2021

    Report

    Report Number
    1221359-2021-02260
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    May 23, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M140253 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 TEST BASE PART NUMBER 190-430 / LOT M140253. 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 0.008% ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. THIS EVENT WAS ORIGINALLY REPORTED IN INITIAL MDR 1221359-2021-01872. REFERENCE MFR NUMBERS: 1221359-2021-01877, 1221359-2021-02261, 1221359-2021-02262.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON (B)(6) 2021. THIS MFR. REPORT ADDRESSES PATIENT 1-3 OF 4. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY FOR THREE PATIENTS PERFORMED ON (B)(6) 2021. THE ID NOW COVID-19 ASSAYS WERE PERFORMED ON DIRECT TESTED NASOPHARYNGEAL KITTED SWABS . THE ID NOW COVID-19 WAS USED TO TEST OUTPATIENT POLYCLINIC FOR PRE-SURGERY AS ROUTINE PATIENT TESTING. ALL RESULTS WERE POSITIVE WITH ID NOW COVID-19, HOWEVER BECAUSE THE PATIENTS WERE ASYMPTOMATIC THE LAB SUSPECTED THAT THE POSITIVE TEST RESULTS USING ID NOW COVID-19 WERE INVALID AND DECIDED TO RE-TAKE THE SWAB FOR PCR TEST WITHIN 1 HOUR AFTER THE ID NOW SWAB. THE PCR SWAB RESULTS FOR THE PATIENTS WERE ALL NEGATIVE AND THE PATIENTS WERE IMMEDIATELY TREATED ACCORDING TO THE REGULAR NON-COVID PROTOCOL. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214915 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH M140253 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1