BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13934540 · Received March 28, 2022

    Report

    Report Number
    1221359-2022-01692
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    February 24, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIMILAR PRODUCT TO 190-000. RELATED MFR. REPORT NUMBERS 1221359-2022-01693 THROUGH 1221359-2022-01701.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1060623 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 191-000 / LOT 1060623 AND TEST BASE PART NUMBER 190-430 / LOT 1060623. 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 1060623 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, THE MANUFACTURING BATCH RECORD REVIEW REVEALED THAT THE PRODUCT MET ACCEPTANCE CRITERIA FOR RELEASE. ABBOTT DIAGNOSTICS SCARBOROUGH 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. REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND HAVE NOT IDENTIFIED A PRODUCT DEFICIENCY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED TEN FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED ON MULTIPLE DAYS AND PATIENTS. THIS REPORT IS FOR PATIENT ONE (1) OF TEN (10). PATIENT WAS TESTED WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022 AT 14:02 O'CLOCK ON A NASOPHARYNGEAL SAMPLE WHICH GENERATED A POSITIVE RESULT. CONFIRMATION PCR TESTING WAS PERFORMED WHICH GENERATED A NEGATIVE RESULT (DATE, PLATFORM AND SAMPLE TYPE UNKNOWN). CUSTOMER INDICATED THAT THE PCR RESULT SHOWED PATIENT'S VIRAL LOAD OF 37. NO FURTHER INFORMATION REGARDING SYMPTOMS, HEALTH IMPACT OR OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20225 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1060623 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown