BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14119059 · Received April 15, 2022

    Report

    Report Number
    1221359-2022-02229
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    April 19, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    04571226475027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 190-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-02226 - 1221359-2022-02232.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATED PATIENT AND EVENT INFORMATION. PLEASE SEE UPDATES: LOT M182932 EXPIRATION DATE 28OCT2022; DEVICE MANUFACTURE DATE 30JAN2022; UDI (B)(4). THE INVESTIGATION IS STILL PENDING. A SUPPLEMENT REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M185870 / M182932 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 KIT PART NUMBER 190-000J / LOT M185870 / M182932 AND TEST BASE PART NUMBER 190-430 / LOT M185870 / M182932. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M185870 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M185870 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M182932 SHOWED THAT THE COMPLAINT RATE IS (B)(4). A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT M182932 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. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE IDNOW COVID-19 ASSAY FOR MULTIPLE PATIENTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT FOUR (4) OF SEVEN (7). THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE IDNOW COVID-19 ASSAY ON AN UNKNOWN DATE ON A NASOPHARYNGEAL SAMPLE. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WITH THE IDNOW COVID-19 ASSAY FOR MULTIPLE PATIENTS ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT FOUR (4) OF SEVEN (7). THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE IDNOW COVID-19 ASSAY ON 28MAR2022 ON A NASOPHARYNGEAL SAMPLE. LOT M185870 WAS USED FOR THE FIRST TEST AND GENERATED A POSITIVE RESULT. LOT M182932 WAS USED FOR THE SECOND TEST AND GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138230 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M185870 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female