BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 13343298 · Received January 25, 2022

    Report

    Report Number
    1221359-2022-00515
    Event Type
    Malfunction
    Date Received
    January 25, 2022
    Report Date
    May 20, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 191-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M170104 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 M170104 AND TEST BASE PART NUMBER 190-430 / LOT M170104. 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 M170104 SHOWED THAT THE COMPLAINT RATE IS (B)(4) AND (B)(4) RESPECTIVELY. IN CONCLUSION, 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A CONFLICTING RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON AN UNKNOWN SAMPLE OR SWAB TYPE. THE CUSTOMER REPORTING THAT THEY HAD RECENTLY GONE THROUGH A COVID-19 INFECTION, THROUGH WHICH THEY HAVE CONSISTENTLY TESTED COVID-19 POSITIVE ON ROCHE-BRAND RAPID TESTS. AS SOON AS PATIENT-1 TESTED NEGATIVE ON ROCHE TESTS, THEY WERE TESTED IN THEIR PHARMACY ON THEIR ID NOW INSTRUMENT(SN (B)(4)) FOR COVID-19 (LOT M170104) WITH NASAL SAMPLES, THE FIRST TWO DAYS YIELDING A POSITIVE RESULT. ON THE THIRD DAY, A NASAL SAMPLE OF THE PATIENT YIELDED A NEGATIVE RESULT, BUT A NASOPHARYNGEAL SAMPLE TAKEN IMMEDIATELY AFTERWARDS YIELDED A POSITIVE RESULT. THE PATIENT IS HAVING A LABORATORY PCR TEST PERFORMED TO ASCERTAIN COVID-19 STATUS. TEST RESULT OUTSTANDING. NO OTHER OCCURRENCES OF PAIN OR DISCOMFORT. NO MEDICAL PROCEDURES WERE BASED ON THE DISCREPANT RESULT AS IT WAS IMMEDIATELY RECOGNIZED AS UNRELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224789 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M170104 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Female