BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14949258 · Received July 7, 2022

    Report

    Report Number
    1221359-2022-03359
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 25, 2022
    Report Date
    July 24, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    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 AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063203 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 WERE REVIEWED FOR KIT PART NUMBER 191-000 / LOT 1063203 AND TEST BASE PART NUMBER 190-430 / LOT 1063203 AND THEY MET SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1063203 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. SUBSTANCES IN THE SAMPLE ITSELF MAY HAVE INTERFERED WITH THE REACTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022 WITH AN UNKNOWN NASAL SWAB (CUSTOMER INDICATED THAT THEY ARE NOT USING THE SWABS PROVIDED IN THE ID NOW PACKAGE). CONFIRMATION PCR TESTING WAS PERFORMED (B)(6) 2022 WHICH GENERATED A NEGATIVE RESULT. THE CUSTOMER NOTED THAT THE PATIENT HAD INGESTED SOME SPRITE ZERO PRIOR TO THE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY. NO MEDICAL TREATMENT WAS DELAY AND NO MEDICAL DECISION WERE MADE BASED ON THE INITIAL POSITIVE RESULT. THE CUSTOMER REPORTED THAT THE PATIENT WAS ASYMPTOMATIC AND WAS NOT IMPACTED OTHER THAN QUARANTINING FOR ONE DAY UNTIL THE PCR RESULTS WERE OBTAINED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372625 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female