BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12637512 · Received October 14, 2021

    Report

    Report Number
    1221359-2021-03177
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Report Date
    December 23, 2021
    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, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 190-000/ LOT 1033315 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 190-430 / LOT 1033315 . TEST BASE PART NUMBER 190-000/ LOT 1033315. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1033315 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 AN ASSIGNABLE ROOT CAUSE AS THE LOGFILES WERE NOT PROVIDED FOR INVESTIGATION, HOWEVER SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION. A REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED. BASED ON THE ABOVE SUMMARY, THE INVESTIGATION IS DEEMED CLOSED. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. PLEASE REFERENCE MFR. REPORT #: 1221359-2021-03099, 1221359-2021-03100, 1221359-2021-03178, 1221359-2021-03179.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TOTAL OF (13) FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY USING FIVE DIFFERENT LOTS (LOT 1035481, LOT 1032993, LOT 1033315, LOT M159436 AND LOT 1032947) PERFORMED ON VARIES DATES. THIS MFR. REPORT ADDRESSES LOT 3 OF 5. THE CUSTOMER REPORTED (4) FOUR FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 ASSAY. THE NASAL SAMPLES WERE COLLECTED ON (B)(6) 2021. TWO CONFIRMATION TESTS WERE PERFORMED BY CORELAB AND GENERATED POSITIVE RESULTS. THE OTHER TWO CONFIRMATION TESTS WERE PERFORMED USING ABBOTT M2000 AND ALSO, GENERATED POSITIVE RESULTS. NASOPHARYNGEAL SAMPLES IN TRANSPORT MEDIA WERE ALSO COLLECTED ON THE SAME DAYS AS THE NASAL SAMPLES. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528003 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1033315 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown