BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 ASSAY

    MDR report key: 11174696 · Received January 14, 2021

    Report

    Report Number
    1221359-2021-00081
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Report Date
    January 28, 2022
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: AFTER FURTHER REVIEW IT WAS IDENTIFIED THE PREVIOUS FOLLOW-UP MDRS WERE INADVERTENTLY SUBMITTED UNDER MFR. REPORT 1221359-2020-00081 INSTEAD OF 1221359-2021-00081. A MAUDE REVIEW WAS DONE OF THE REPORT 1221359-2020-00081 AND ALTHOUGH THE LAST SUBMISSION DATE SHOWS AS 19FEB2021 (THE SUBMISSION OF FOLLOW-UP 1 THAT WAS INTENDED FOR 12213159-2021-00081), THE INVESTIGATION CONCLUSION IS CORRECT AND DID NOT CHANGE BASED ON THIS ERROR. THEREFORE, WE WILL NOT BE SUBMITTING ANY MODIFICATIONS UNDER THAT MFR. REPORT # TO REDUCE FURTHER CONFUSION. ADDITIONAL INFORMATION - INVESTIGATION CONCLUSION: TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 1013833 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: 1013833, TEST BASE PART NUMBER 190-000/ LOT: 1013833. 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 1013833 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, IT COULD POSSIBLY BE RELATED TO SPECIFIC PATIENT SAMPLE, CROSS CONTAMINATION OR ENVIRONMENTAL CONTAMINATION.

    Additional Manufacturer Narrative · 1

    THE CURRENT OVERALL INCIDENT RATE FOR FALSE POSITIVES RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) FOR THIS SPECIFIC LOT BASED ON THE TOTAL QUANTITY OF DEVICES DISTRIBUTED IS (B)(4). THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION.

    Description of Event or Problem · 1

    CUSTOMER CALLED AND REPORTED UNUSUAL HIGH POSITIVE RATE FOR ID NOW COVID-19 SINCE THEY WENT LIVE ON (B)(6) 2020. CUSTOMER STATED THE FIRST DAY THEY WENT LIVE, 20 OUT OF 30 BOOKED APPOINTMENTS TESTED POSITIVE. CUSTOMER STATED THEY CLEANED THE INSTRUMENT AFTER EACH POSITIVE RESULT WITH 70% ETHANOL AND CHANGED GLOVES AND PPE. THEY HAVE CANCELLED ALL APPOINTMENTS AT THIS TIME DUE TO HIGH NUMBER OF POSITIVE RESULTS. NO ADDITIONAL INFORMATION WAS PROVIDED ON WHETHER REPEAT TESTING OR CONFIRMATION TESTING WAS PERFORMED. NO ADDITIONAL PATIENTS INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED. NO PATIENT HARM/DELAY/IMPACT ON THE PATIENT'S TREATMENT WAS REPORTED. POSITIVE RESULTS ARE INDICATIVE OF THE PRESENCE OF SARS-COV-2 RNA; CLINICAL CORRELATION WITH PATIENT HISTORY AND OTHER DIAGNOSTIC INFORMATION IS NECESSARY TO DETERMINE PATIENT INFECTION STATUS. POSITIVE RESULTS DO NOT RULE OUT BACTERIAL INFECTION OR CO-INFECTION WITH OTHER VIRUSES. DUE TO THE HIGH SENSITIVITY OF THE ASSAYS RUN ON THE INSTRUMENT, CONTAMINATION OF THE WORK AREA WITH PREVIOUS POSITIVE SAMPLES MAY CAUSE FALSE POSITIVE RESULTS. HANDLE SAMPLES ACCORDING TO STANDARD LABORATORY PRACTICES. CLEAN INSTRUMENTS AND SURROUNDING SURFACES ACCORDING TO INSTRUCTIONS PROVIDED IN THE CLEANING SECTION OF THE INSTRUMENT USER MANUAL. DUE TO THE RISK OF A FALSE POSITIVE RESULT LEADING TO POSSIBLE EXPOSURE TO COVID-19 THROUGH THE QUARANTINE OF THE FALSE POSITIVE PATIENT WITH TRUE POSITIVE PATIENT(S), DELAYED EMERGENCY TREATMENT AND/OR INAPPROPRIATE TREATMENT WITH ANTIVIRAL THERAPY, THE INCIDENT SHALL BE CONSIDERED REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68409 ID NOW COVID-19 ASSAY MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1013833 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown