BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 TEST KIT 24T (OUS)

    MDR report key: 15657351 · Received October 24, 2022

    Report

    Report Number
    1221359-2022-10021
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 18, 2022
    Report Date
    February 3, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M185210 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: M185210, TEST BASE PART NUMBER 190-430/ LOT: M185210. 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 M185210 SHOWED THAT THE COMPLAINT RATE IS (B)(4).. 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. H3 OTHER TEXT : DEVICE DISCARDED; SINGLE USE DEVICE

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 TEST KIT 24T PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED COPAN FLOCK NASOPHARYNGEAL SWAB AND GENERATED A POSITIVE RESULT. PCR CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY WITH A NEW SAMPLE AND GENERATED A NEGATIVE RESULT (CT VALUES NOT PROVIDED). THE PRIMARY SAMPLE (DRY SWAB) WAS PROCESSED AGAIN TO CONFIRM THE FIRST ID NOW RESULT AND AGAIN A POSITIVE RESULT WAS OBTAINED. IN ADDITION, THE CUSTOMER REPORTED THAT REPEAT TESTING WAS PERFORMED WITH THE ID NOW USING A NEW SAMPLE AND GENERATED A NEGATIVE RESULT. THE PATIENT¿S FILMARRAY RESPIRATORY PANEL WAS ALSO NEGATIVE. THE PATIENT¿S OUTCOME IS UNKNOWN; HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO PATIENT TREATMENT PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 TEST KIT 24T PERFORMED 18SEP2022 ON A DIRECT TESTED COPAN FLOCK NASOPHARYNGEAL SWAB AND GENERATED A POSITIVE RESULT. PCR CONFIRMATION TESTING WAS PERFORMED ON THE SAME DAY WITH A NEW SAMPLE AND GENERATED A NEGATIVE RESULT (CT VALUES NOT PROVIDED). THE "PRIMARY" SAMPLE (DRY SWAB) WAS PROCESSED AGAIN TO CONFIRM THE FIRST ID NOW RESULT AND AGAIN A POSITIVE RESULT WAS OBTAINED. IN ADDITION, THE CUSTOMER REPORTED THAT REPEAT TESTING WAS PERFORMED WITH THE ID NOW USING A NEW SAMPLE AND GENERATED A NEGATIVE RESULT. THE PATIENT¿S FILMARRAY RESPIRATORY PANEL WAS ALSO NEGATIVE. THE PATIENT¿S OUTCOME IS UNKNOWN; HOWEVER, THE CUSTOMER CONFIRMED THERE WAS NO PATIENT TREATMENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495327 ID NOW COVID-19 TEST KIT 24T (OUS) MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M185210

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female