BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12763816 · Received November 7, 2021

    Report

    Report Number
    1221359-2021-03382
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    September 30, 2021
    Report Date
    November 30, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    UDI-DI
    04571226475027
    PMA / PMN Number
    EUA2000074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M162309 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 190-000J / LOT M162309 AND TEST BASE PART NUMBER 190-430 / LOT M162309. 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 M162309 SHOWED THAT THE COMPLAINT RATE IS (B)(4).. ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MANUFACTURE REPORT NUMBER: 1221359-2021-03383.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT RESULTS WITH THE ID NOW COVID-19 ASSAY FOR MULTIPLE PATIENTS PERFORMED ON VARIOUS DATES. THIS MFR. REPORT ADDRESSES PATIENT 1 OF 2. THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON (B)(6) 2021 ON A DIRECT TESTED NASOPHARYNGEAL NIPRO SWAB. REPEAT TESTING WAS PERFORMED ON THE SAME DAY ((B)(6)2021) WITH PCR GENERATING NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER REPORTED THERE WAS A DELAY IN THE PATIENT'S TREATMENT. THE PATIENT EXPERIENCED A DELAY IN PATIENT ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658789 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH M162309 04571226475027

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other