BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 15157681 · Received August 3, 2022

    Report

    Report Number
    1221359-2022-03459
    Event Type
    Malfunction
    Date Received
    August 3, 2022
    Date of Event
    April 15, 2022
    Report Date
    August 11, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. REFERENCE RELATED MFR REPORT NUMBERS: 1221359-2022-03462.

    Additional Manufacturer Narrative · 0

    INVESTIGATION REPORT: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1063237 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 1063237 AND TEST BASE PART NUMBER 190-430 / LOT 1063237. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 1063237 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 SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED WITH NASOPHARYNGEAL SAMPLES ON ENAT FLOWQ SWABS (REGULAR TIP 552C) ON VARIOUS DATES IN 2022. THIS REPORT IS FOR PATIENT ONE (1) OF FOUR (4) AND FOR LOT NUMBER 1063237 (QUANTITY 1). THE PATIENT TESTED POSITIVE WITH THE ID NOW COVID-19 ASSAY ON (B)(6) 2022. THE PATIENT WAS RETESTED ON A DIFFERENT ID NOW COVID-19 ASSAY ON AN UNKNOWN DATE WHICH GENERATED A NEGATIVE RESULT. CONFIRMATION PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED ON AN UNKNOWN DATE WHICH GENERATED NEGATIVE RESULTS. THE CUSTOMER INDICATED THAT THERE WAS NO IMPACT TO THE PATIENT OR PATIENT TREATMENT. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545049 ID NOW COVID-19 ASSAY REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1063237 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Female