BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14269058 · Received May 3, 2022

    Report

    Report Number
    1221359-2022-02277
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 26, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SIMILAR PRODUCT TO 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063043 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 1063043 AND TEST BASE PART NUMBER 190-430 / LOT 1063043. 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 1063043 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, AS THE LOGFILES WERE NOT PROVIDED. REVIEW OF COMPLAINTS AGAINST THE KIT LOT(S) FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND HAVE NOT IDENTIFIED A PRODUCT DEFICIENCY. THE PRODUCT WILL CONTINUE TO BE MONITORED AND TRACKED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNCONFIRMED FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022. THE PATIENT TESTED WITH ANOTHER ASSAY (PLATFORM AND SAMPLE TYPE UNKNOWN) ON (B)(6) 2022. WHICH GENERATED A NEGATIVE RESULT. NO FURTHER INFORMATION REGARDING PATIENT HEALTH AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317710 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063043 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown