BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15739131 · Received November 4, 2022

    Report

    Report Number
    1221359-2022-05234
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    October 24, 2022
    Report Date
    February 2, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER EXPERIENCED FALSE RESULTS WITH TWO LOTS BUT IS UNABLE TO DETERMINE THE TOTAL QUANTITY PER LOT. SEE BELOW FOR INFORMATION RELATED TO BOTH REPORTED LOTS: LOT NUMBER; M211725 EXPIRATION DATE; 06MAY2022, LOT NUMBER; M213947 EXPIRATION DATE; 08MAY2022. PMA/510K: SIMILAR PRODUCT TO 190-000. DEVICE MANUFATURE DATE: LOT# M211725: 08AUG2022; LOT# M213947: 10AUG2022. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE RELATED MFG. REPORT NUMBERS 1221359-2022-05226 THROUGH 1221359-2022-05235.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M211725 AND M213947 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 M211725 AND TEST BASE PART NUMBER 190-430 / LOT M211725 AS WELL AS KIT PART NUMBER 190-000J / LOT M213947 AND TEST BASE PART NUMBER 190-430 / LOT M21394. THE LOTS 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 M211725 AND M213947 SHOWED THAT THE COMPLAINT RATE IS (B)(4) AND (B)(4) RESPECTIVELY. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE AS THE LOGFILES WERE NOT RETURNED FOR ANALYSIS. HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TEN (10) UNCONFIRMED FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022 WITH TWO (2) LOT NUMBERS (M211725 AND M213947). THE CUSTOMER IS UNABLE TO PROVIDE THE TOTAL NUMBER OF FALSE POSITIVE RESULTS PER LOT. THIS REPORT IS FOR RESULTS NINE (9) OF TEN (10). THE CUSTOMER QUESTIONED THE ID NOW COVID-19 ASSAY RESULTS EVEN THOUGH NO CONFIRMATION OR REPEAT TESTING WAS PERFORMED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2251320 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown