BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 13806354 · Received March 18, 2022

    Report

    Report Number
    1221359-2022-01687
    Event Type
    Malfunction
    Date Received
    March 18, 2022
    Date of Event
    February 20, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    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. REFERENCE MFR REPORT NUMBERS: 1221359-2022-01681 THROUGH 1221359-2022-01691.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M174237 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 M174237 AND TEST BASE PART NUMBER 190-430 / LOT M174237. 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 M174237 SHOWED THAT THE COMPLAINT RATE IS (B)(4).. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, AS THE LOG FILES WERE NOT PROVIDED. REFERENCE MFR REPORT NUMBERS: (B)(4) THROUGH (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ELEVEN (11) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED IN BETWEEN (B)(6) 2022 TO (B)(6) 2022. THIS MFR. REPORT ADDRESSES FALSE POSITIVE SEVEN (7) AND IS SEVEN (7) OF ELEVEN (11). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY ON NASOPHARYNGEAL SWAB. PCR CONFIRMATION TESTING GENERATED A NEGATIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2187316 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M174237 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown