BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11997185 · Received June 15, 2021

    Report

    Report Number
    1221359-2021-01737
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 11, 2021
    Report Date
    December 5, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCABOROUGH
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M142049 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 M142049 AND TEST BASE NUMBER 190-430 / LOT M142049. 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 M142049 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE AS THE LOGFILES WERE NOT PROVIDED. A REVIEW OF COMPLAINTS AGAINST THE KIT LOT FOR THE REPORTED ISSUE INDICATES PRODUCT PERFORMANCE IS AS EXPECTED AND A PRODUCT DEFICIENCY HAS NOT BEEN IDENTIFIED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT YET COMPLETE. UPON COMPLETION, THE INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. RELATED MANUFACTURE REPORT NUMBERS (B)(4), 1221359-2021-01738, 1221359-2021-01739.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS WHILE USING THE ID NOW COVID-10 ASSAY TO TEST THREE (3) PATIENTS. THIS MFR. REPORT IS ONE (1) OF THREE (3). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 ASSAY PERFORMED ON NEW SAMPLE (B)(6) 2021 ON A DIRECT TESTE4D NASAL KITTED SWAB. REPEAT TESTING WAS PERFORMED ON (B)(6) 2021 WITH NEGATIVE RESULTS. CONFIRMATION TESTING ON (B)(6) 2021 (LABCORP) WITH NEGATIVE RESULTS AND (B)(6) 2021 SAMPLE COLLECTED (B)(6) 2021 WITH NEGATIVE RESULTS. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM DUE TO THE TEST RESULTS. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY. THE PATIENT EXPERIENCED EXTENDED TIME UNDER MEDICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898822 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCABOROUGH M142049

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Unknown Hospitalization