BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 14034114 · Received April 6, 2022

    Report

    Report Number
    1221359-2022-01563
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 14, 2022
    Report Date
    June 21, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 191-000 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 190-000. THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR. REPORTS: 1221359-2022-01559 - 1221359-2022-01564.

    Additional Manufacturer Narrative · 0

    ADDITIONAL: D4 (EXP. DATE) AND H4. INVESTIGATION REPORT: TESTING WAS PERFORMED IN DUPLICATE AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1060928 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 1060928 AND TEST BASE PART NUMBER 190-430 / LOT 1060928. 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 1060928 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE; HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE ROOT CAUSE IS CROSS CONTAMINATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY FOR MULTIPLE LOTS. THIS MFR. REPORT ADDRESSES PATIENT FIVE (5) OF SIX (6) AND LOT 1060928. THE NUMBER OF TESTS PERFORMED WITH EACH LOT WAS NOT PROVIDED. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE IDNOW COVID-19 ASSAY FOR PERFORMED ON (B)(6) 2022 ON A DIRECT TESTED KIT SWAB. PCR CONFIRMATION TESTING (PLATFORM: CEPHEID GENEXPERT) FROM A SAMPLE IN VIRAL TRANSPORT MEDIA ON (B)(6) 2022 GENERATED NEGATIVE RESULTS. NO ADDITIONAL INFORMATION, INCLUDING PATIENT TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824123 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1060928 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown