BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 12321581 · Received August 13, 2021

    Report

    Report Number
    1221359-2021-02261
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT M140253 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 TEST BASE PART NUMBER 190-430 / LOT M140253. 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 (B)(4) ABBOTT DIAGNOSTICS (B)(4) WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION. THIS EVENT WAS ORIGINALLY REPORTED IN FOLLOW MDR # 1 1221359-2021-01872. REFERENCE MFR NUMBERS: 1221359-2021-01877, 1221359-2021-02260, 1221359-2021-02262.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCREPANT POSITIVE TEST RESULT FOR ID NOW COVID-19 THAT TESTED NEGATIVE ON PCR TEST. THE CUSTOMER REPORTED THAT THE PATIENT WAS SYMPTOMATIC PRESENTING TO THE EMERGENCY ROOM FEVER AND HEADACHE. THE PATIENT RECEIVED POSITIVE RESULTS WITH ID NOW. PCR CONFIRMATION TESTING GENERATED NEGATIVE RESULTS. THE PULMONOLOGIST HAD TAKEN THE PATIENT FOR X-RAY TEST, BUT THE CLINICAL PATHOLOGIST DID NOT KNOW THE RESULT WHETHER THIS PATIENT HAD PNEUMONIA OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214784 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH M140253 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1