BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 12532084 · Received September 27, 2021

    Report

    Report Number
    1221359-2021-02808
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    August 31, 2021
    Report Date
    November 10, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011320
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO NEW INFORMATION IT SHOWS THAT THIS REPORT IS FOR ONE PATIENT. THE PATIENT HAD GASTRIC ULCERS AND STOMACH CANCER IN HIS 70'S. MAKING MDR 1221359-2021-02809 NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M161636 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 190-000 / LOT: M161636, TEST BASE PART NUMBER 190-430 / LOT: M161636. 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 M161636 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER A POSSIBLE ASSIGNABLE ROOT CAUSE IS SAMPLE INTERFERENCE OR CROSS CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE PROVIDED. REFERENCE MFR. REPORT: 1221359-2021-02809.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED POTENTIALLY A TOTAL OF THREE (3) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY PERFORMED WITH TWO PATIENTS. HOWEVER, BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, IT IS NOT CLEAR WHICH PATIENT HAD TWO FALSE POSITIVE RESULTS. THIS MFR. ADDRESSES PATIENT (1) OF (2). THE CUSTOMER REPORTED ONE (POTENTIALLY TWO) FALSE POSITIVE RESULT ON A DIRECT TESTED NASOPHARYNGEAL MENTIP 1PX1503P SWAB WITH ID NOW COVID-19 PERFORMED ON (B)(6) 2021. CONFIRMATION TESTING WAS PERFORMED WITH LAMP, PCR, AND ANTIGEN AND THAT PROVIDED NEGATIVE RESULTS, (CT VALUES NOT PROVIDED). PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC WITH VOMITING. PER THE CUSTOMER, IT TOOK THE PATIENT 5 HOURS TO FIND A HOSPITAL THAT CAN TAKE COVID PATIENTS DUE TO THE RESULT. THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL. ADDITIONALLY, THERE WAS NO PATIENT IMPACT DUE TO TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431694 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. M161636 10811877011320

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Unknown