BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 11829495 · Received May 14, 2021

    Report

    Report Number
    1221359-2021-01496
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    February 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. (B)(6). REFERENCE MFR REPORTS: 1221359-2021-01367, 1221359-2021-01491, 1221359-2021-01492, 1221359-2021-01493, 1221359-2021-01494, 1221359-2021-01495, 1221359-2021-01497.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1013549 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 1013549, TEST BASE PART NUMBER 190-430 / LOT 1013549. 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 1013549 SHOWED THAT THE COMPLAINT RATE IS (B)(4). IN CONCLUSION, ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, IT COULD POSSIBLY BE RELATED TO THE SPECIFIC PATIENT SAMPLE OR CROSS CONTAMINATION. REFERENCE MFR REPORTS: 1221359-2021-01367, 1221359-2021-01491, 1221359-2021-01492, 1221359-2021-01493, 1221359-2021-01494, 1221359-2021-01495, 1221359-2021-01497.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED MULTIPLE FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED BETWEEN (B)(6) 2021 AND (B)(6) 2021 FOR 13 PATIENTS. THIS MFR. REPORT ADDRESSES PATIENT TWELVE (12) AND IS SEVEN (7) OF EIGHT (8). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE IDNOW ASSAY ON (B)(6) 2021. ON THE SAME DAY PCR CONFIRMATION TESTING USING TAQPATH THERMOFISHER PLATFORM GENERATED NEGATIVE RESULTS. PER THE CUSTOMER THE PATIENT WAS SYMPTOMATIC HAVE FEEL AND LIGHT DYSPNEA. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721743 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013549

    Patients

    Seq Age Sex Outcome Treatment
    1