BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14429429 · Received May 18, 2022

    Report

    Report Number
    1221359-2022-02294
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 27, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SIMILAR PRODUCT TO 190-000. INVESTIGATION SUMMARY: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1063244 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 1063244 AND TEST BASE PART NUMBER 190-430 / LOT 1063244. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. THE CURRENT OVERALL INCIDENT RATE FOR FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS (B)(4). THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS (B)(4) BASED ON THE EVIDENCE AVAILABLE, THIS DEVICE LOT IS PERFORMING AS EXPECTED. IN CONCLUSION, THE RETENTION TESTING YIELDED EXPECTED RESULTS WHEN TESTING INTERNAL QC SAMPLES. 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.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED CONFLICTING RESULTS WHEN TESTING A NASAL SWAB SAMPLE ON THE ID NOW COVID-19 ASSAY ON (B)(6) 2022. THE PATIENT'S FIRST SAMPLE GENERATED A POSITIVE RESULT. DUE TO THE POSITIVE RESULT, THE PATIENT WAS IMMEDIATELY RETESTED ON THE SAME ID NOW COVID-10 ASSAY USING A NEWLY COLLECTED NASAL SAMPLE WHICH GENERATED A NEGATIVE RESULT. THE PATIENT WAS REPORTED TO BE SYMPTOMATIC. NO FURTHER INFORMATION WAS PROVIDED REGARDING HEALTH STATUS AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502909 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063244 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown