BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12695003 · Received October 25, 2021

    Report

    Report Number
    1221359-2021-03293
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 17, 2021
    Report Date
    January 31, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE INVESTIGATION CONCLUSION. ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THERE WAS NO ISSUE AS OF NOW AS THE INSTRUMENT WAS REPLACED. INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M160812 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 190-000 / LOT M160812 AND TEST BASE PART NUMBER 190-430 / LOT M160812. 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 M160812 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. 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 CROSS CONTAMINATION. A REVIEW OF COMPLAINTS AGAINST THE KIT LOTS FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND HAVE NOT IDENTIFIED A PRODUCT DEFICIENCY. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE RELATED MFR. REPORT NUMBERS: 1221359-2021-03290, 1221359-2021-03291, 1221359-2021-03292, 1221359-2021-03294, 1221359-2021-03295, 1221359-2021-03296, 1221359-2021-03297, 1221359-2021-03298, 1221359-2021-03299, 1221359-2021-03300, 1221359-2021-03301,1221359-2021-03302,1221359-2021-03303 AND 1221359-2021-03304.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A TOTAL OF 36 FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY USING TWO DIFFERENT LOTS (LOT M160812 AND LOT M160939) ACROSS MULTIPLE DAYS. THESE 36 FALSE POSITIVE RESULTS ARE BEING REPORTED IN 15 MFR. REPORTS. EACH REPORT COVERS THE FALSE POSITIVE RESULT(S) ON EACH TESTING DAY WITH EACH LOT. THIS MFR. REPORT IS 4 OF THE 15 REPORTS AND COVERS (1) ONE FALSE POSITIVE RESULT ON (B)(6) 2021 WITH LOT # M160812. THE CUSTOMER REPORTED (1) ONE FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON NASAL KITTED SWAB SAMPLES. REPEAT TEST WAS PERFORMED WITH THE FRESH SAMPLE USING ANOTHER INSTRUMENT. RT PCR CONFIRMATION TESTING WAS PERFORMED HALF AN HOUR AFTER TESTING ON NASAL SWAB SAMPLES AND ALL TEST GENERATED NEGATIVE RESULTS (CT VALUES NOT PROVIDED). THE CUSTOMER REPORTED THAT THERE WAS NO BLOOD OBSERVED IN THE SAMPLES. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585237 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M160812 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown