BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 13832068 · Received March 20, 2022

    Report

    Report Number
    1221359-2022-01706
    Event Type
    Malfunction
    Date Received
    March 20, 2022
    Date of Event
    February 26, 2022
    Report Date
    March 19, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1060760 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: 1060760, TEST BASE PART NUMBER 190-430 / LOT: 1060760. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE AND FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1060760 SHOWED THAT THE COMPLAINT RATE IS 0.020%. 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. REFERENCE MFR REPORT NUMBERS: 1221359-2022-01702 THROUGH 1221359-2022-01711.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) CONFLICTING RESULTS WITH THE ID NOW COVID-19 ASSAY FOR TEN (10) PATIENTS PERFORMED ON (B)(6) 2022. THIS MFR. REPORT ADDRESSES PATIENT FIVE (5) AND IS FIVE (5) OF TEN (10). THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY TESTED ON A NASAL KITTED SWAB. CUSTOMER MENTIONED SOME PATIENTS WERE CLOSE CONTACT AND HAD SYMPTOMS. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651616 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1060760 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown