BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 20134688 · Received September 4, 2024

    Report

    Report Number
    1221359-2024-00593
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QWR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. A PRODUCT DEFICIENCY COULD NOT BE DETERMINED. NOTWITHSTANDING, COMPLAINTS AGAINST THESE TREND CODES ARE MONITORED TO IDENTIFY AND TRACK ANY OUT-OF-TREND/UNEXPECTED PERFORMANCE AT THE LOT AND PRODUCT FAMILY LEVEL.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D2A: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 192-000J THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 192-000. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OR UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY ON AN UNKNOWN DATE(S). CONFIRMATORY PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED THE DAY AFTER THE ID NOW 2.0 ASSAY WHICH GENERATED POSITIVE RESULTS. THERE WAS NO HARM OR DELAY IN TREATMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF FALSE NEGATIVE RESULTS WITH THE ID NOW COVID-19 2.0 ASSAY ON AN UNKNOWN DATE(S). CONFIRMATORY PCR TESTING (PLATFORM UNKNOWN) WAS PERFORMED THE DAY AFTER THE ID NOW 2.0 ASSAY WHICH GENERATED POSITIVE RESULTS. THERE WAS NO HARM OR DELAY IN TREATMENT REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108225 ID NOW COVID-19 2.0 TEST KIT 24T JAPAN SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS QWR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown