BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    MDR report key: 16466777 · Received March 2, 2023

    Report

    Report Number
    1221359-2023-00418
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    January 23, 2023
    Report Date
    May 5, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    00811877011354
    PMA / PMN Number
    EUA210517
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REMAINDER OF THE INVESTIGATION REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. SINGLE USE; DEVICE DISCARDED.

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1090117 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 KIT PART NUMBER 192-000 / LOT 1090117 AND TEST BASE PART NUMBER 192-430 / LOT 1090117. 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 1090117 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE HOWEVER, A POSSIBLE ASSIGNABLE ROOT CAUSE IS PATIENT SAMPLE INTERFERENCE. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 TEST KIT FOR MULTIPLE PATIENTS AND TESTS, BUT THE SAME LOT NUMBER, PERFORMED ON VARYING DATES BETWEEN (B)(6) 2023 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES PATIENT AND TEST TWO (2) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 TEST KIT PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA UNKNOWN PCR WAS PERFORMED USING AN UNKNOWN SAMPLE TYPE AND GENERATED A NEGATIVE RESULT. THE CONFIRMATORY SAMPLE WAS COLLECTED ON-SITE ON (B)(6) 2023 AND SENT TO AN OFF-SITE LAB FOR TESTING. IT WAS REPORTED THAT THE SAMPLE WAS REFRIGERATED FOR THREE (3) DAYS BEFORE A RESULT WAS GENERATED ON (B)(6) 2023. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF TESTING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED A TWO TO THREE (2-3) DAY DELAY IN ADMITTANCE TO IN-PERSON COUNSELING FOR ADDICTION TREATMENT DUE TO THE TEST RESULTS, HOWEVER, THE CUSTOMER ALSO CONFIRMED THAT THE PATIENT RECEIVED ALL NECESSARY MEDICAL TREATMENT THAT WAS REQUIRED. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 2.0 TEST KIT FOR MULTIPLE PATIENTS AND TESTS, BUT THE SAME LOT NUMBER, PERFORMED ON VARYING DATES BETWEEN (B)(6) 2023 AND (B)(6) 2023. THIS MFR. REPORT ADDRESSES PATIENT AND TEST TWO (2) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULT WITH THE ID NOW COVID-19 2.0 TEST KIT PERFORMED ON (B)(6) 2023 ON A NASAL SAMPLE. CONFIRMATION TESTING VIA UNKNOWN PCR WAS PERFORMED USING AN UNKNOWN SAMPLE TYPE AND GENERATED A NEGATIVE RESULT. THE CONFIRMATORY SAMPLE WAS COLLECTED ON-SITE ON (B)(6) 2023 AND SENT TO AN OFF-SITE LAB FOR TESTING. IT WAS REPORTED THAT THE SAMPLE WAS REFRIGERATED FOR THREE (3) DAYS BEFORE A RESULT WAS GENERATED ON (B)(6) 2023. THE CUSTOMER STATED THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF TESTING. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. THE CUSTOMER REPORTED THE PATIENT EXPERIENCED A TWO TO THREE (2-3) DAY DELAY IN ADMITTANCE TO IN-PERSON COUNSELING FOR ADDICTION TREATMENT DUE TO THE TEST RESULTS, HOWEVER, THE CUSTOMER ALSO CONFIRMED THAT THE PATIENT RECEIVED ALL NECESSARY MEDICAL TREATMENT THAT WAS REQUIRED. ADDITIONALLY, THE CUSTOMER CONFIRMED THERE WAS NO DELAY OR IMPACT IN THE PATIENT'S TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454175 ID NOW COVID-19 2.0 TEST KIT 24T (EUA) REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1090117 00811877011354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown