BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T OUS

    MDR report key: 16330037 · Received February 8, 2023

    Report

    Report Number
    1221359-2023-00259
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 31, 2023
    Report Date
    April 20, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M216420 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 193-000 / LOT M216420, TEST BASE PART NUMBER 193-430 / LOT M216420. 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 M216420 SHOWED THAT THE COMPLAINT RATE IS (B)(4)% AND (B)(4)% RESPECTIVELY. 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. H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H4 THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 193-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M216420 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 193-000 / LOT M216420, TEST BASE PART NUMBER 193-430 / LOT M216420. 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 M216420 SHOWED THAT THE COMPLAINT RATE IS (B)(4)% AND (B)(4)% RESPECTIVELY. 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.CORRECTED: H10 - FALSE NEGATIVE COMPLAINT RATE: (B)(4)% H3 OTHER TEXT : SINGLE-USE, DEVICE DISCARDED

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION OR UPON RECEIPT OF NEW INFORMATION. SINGLE-USE, DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE CONFLICTING RESULT AND ONE FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY FOR TWO PATIENTS PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 DIRECTLY TESTED ON A NASAL SWAB. INITIAL TEST WAS POSITIVE. REPEAT TESTING (X2) WAS PERFORMED ON THE SAME DAY AND GENERATED A NEGATIVE RESULT AND POSITIVE RESULT RESPECTIVELY. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. HOWEVER, STATED THAT THERE WAS A DELAY IN SURGERY DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE CONFLICTING RESULT AND ONE FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY FOR TWO PATIENTS PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES PATIENT ONE (1) OF TWO (2). THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY PERFORMED ON (B)(6) 2023 DIRECTLY TESTED ON A NASAL SWAB. INITIAL TEST WAS POSITIVE. REPEAT TESTING (X2) WAS PERFORMED ON THE SAME DAY AND GENERATED A NEGATIVE RESULT AND POSITIVE RESULT RESPECTIVELY. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. HOWEVER, STATED THAT THERE WAS A DELAY IN SURGERY DUE TO THE TEST RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE CONFLICTING RESULT AND ONE FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 ASSAY FOR TWO PATIENTS PERFORMED ON (B)(6) 2023. THIS MFR. REPORT ADDRESSES PATIENT 1(ONE) OF 2 (TWO). THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY FOR PERFORMED ON (B)(6) 2023 DIRECTLY TESTED ON A NASAL SWAB. INITIAL TEST WAS POSITIVE. REPEAT TESTING (X2) WAS PERFORMED ON THE SAME DAY AND GENERATED A NEGATIVE RESULT AND POSITIVE RESULT RESPECTIVELY. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. HOWEVER, STATED THAT THERE WAS A DELAY IN SURGERY DUE TO THE TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606503 ID NOW COVID-19 2.0 TEST KIT 24T OUS REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M216420

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown