BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID 19 ASSAY

    MDR report key: 11823331 · Received May 13, 2021

    Report

    Report Number
    1221359-2021-01482
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 9, 2021
    Report Date
    August 4, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1014005 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 1014005, TEST BASE PART NUMBER 190-430 / LOT 1014005. 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 1014005 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS DEVICE LOT IS PERFORMING WITHIN THE STATEMENTS MADE WITHIN PACKAGE INSERT RELATED TO % TEST AGREEMENT WITH THE EXPECTED RESULTS BY SAMPLE CONCENTRATION. REFERENCE MFR REPORTS: 1221359-2021-01481, 1221359-2021-01490.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. REFERENCE MFR REPORTS: 1221359-2021-01481, 1221359-2021-01490.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THREE (3) FALSE POSITIVE RESULTS WITH THE IDNOW COVID-19 ASSAY FOR TWO (2) PATIENTS ON DIFFERENT DATES. THIS MFR. REPORT ADDRESSES PATIENT TWO (2) AND IS THREE (3) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT ON DIRECT TESTED NOSE/THROAT KITTED SWABS FOR THE PATIENT DURING TESTING WITH THE IDNOW COVID-19 ASSAY ON (B)(6) 2021 . REPEAT TESTING WAS NOT PERFORMED. RT-PCR CONFIRMATION TESTING PERFORMED ON (B)(6) 2021 USING THE SOLARIS MULTIPLEX SARS-COV-2 ANALYSIS ON NASAL/THROAT SWABS GENERATED NEGATIVE RESULTS. PER THE PHYSICIAN, PER SOLARIS THE TEST WAS CUT OFF AND CONSIDERED TO BE NEGATIVE AT CT VALUE=33. IT WAS NOTED THERE WAS 20 HOURS AND 25 MINUTES BETWEEN SPECIMEN COLLECTION AND TEST COMPLETION PER THE CUSTOMER THE PATIENT WAS NOT SYMPTOMATIC AND NO PATIENT HARM, IMPACT OR DELAY TO TREATMENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713055 ID NOW COVID 19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1014005

    Patients

    Seq Age Sex Outcome Treatment
    1