BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 11301032 · Received February 9, 2021

    Report

    Report Number
    1221359-2021-00265
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    December 19, 2020
    Report Date
    February 8, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    UDI-DI
    10811877011269
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO MRN: 1221359-2021-00263, 1221359-2021-00264, 1221359-2021-00266. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS (B)(4), INC. ON RETAINED KIT LOT 1012791 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING BATCH RECORDS AND QUALITY CONTROL RELEASE TESTING FOR KIT PART NUMBER 190-000 / LOT 1012791 AND TEST BASE PART NUMBER 190-430 / LOT 1012791 WERE REVIEWED. THIS 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 1012791 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS (B)(4), 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.

    Description of Event or Problem · 1

    A CUSTOMER SENT A CUMULATIVE REPORT OF FOUR (4) FALSE POSITIVE RESULTS WITH THE ID NOW COVID-19 ASSAY GENERATED ACROSS TWO (2) DIFFERENT TESTING SITES. THIS REPORT REPRESENTS PATIENT THREE (3) OF FOUR (4). THE CUSTOMER REPORTED A FALSE POSITIVE RESULTS USING A NASAL SWAB WITH THE ID NOW COVID-19 TEST. SPECIMEN COLLECTION OCCURRED ON (B)(6) 2020; TESTING DATE AND TIME IS UNKNOWN. CONFIRMATION TESTING WITH A NASOPHARYNGEAL SWAB IN VIRAL TRANSPORT MEDIA WITH CORE LAB PROVIDED NEGATIVE RESULTS. CONFIRMATORY SPECIMEN COLLECTION OCCURRED (B)(6) 2020; TESTING DATE AND TIME IS UNKNOWN. ADDITIONAL PATIENT INFORMATION, INCLUDING SYMPTOMS, TREATMENT AND OUTCOME, IS UNKNOWN. NO ADDITIONAL INFORMATION WILL BE PROVIDED. PER THE ID NOW COVID-19 PRODUCT INSERT, PRECAUTIONS INCLUDE: 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
    197969 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 1012791 10811877011269

    Patients

    Seq Age Sex Outcome Treatment
    1