BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    MDR report key: 20751338 · Received November 21, 2024

    Report

    Report Number
    1221359-2024-00681
    Event Type
    Malfunction
    Date Received
    November 21, 2024
    Date of Event
    November 1, 2024
    Report Date
    April 21, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QWR
    UDI-DI
    04571226475447
    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 - DATE OF EVENT: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D2A - COMMON DEVICE NAME: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4 - PMA/510(K) #: 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.

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D2A - COMMON DEVICE NAME: SIMPLE POINT-OF-CARE DEVICE TO DETECT SAR-COV-2 NUCLEIC ACID TARGETS FROM CLINICAL SPECIMENS IN NEAR-PATIENT SETTINGS G4 - PMA/510(K) #: 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. CORRECTION: H10 - RELATED REPORT NUMBERS: NI TO BLANK. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT M904212 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 192-000J / LOT 000M904212 AND DEVICE PART NUMBER 192-430 / LOT 000M904212. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 2.0 ASSAY PERFORMED ON AN UNKNOWN DATE. THIS REPORT IS FOR PATIENT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 2.0 ASSAY PERFORMED ON AN UNKNOWN DATE. THE PATIENT WAS SYMPTOMATIC. CONFIRMATORY AND REPEAT TESTING WERE NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TWO (2) FALSE NEGATIVE RESULTS WITH THE BINAXNOW COVID-19 2.0 ASSAY PERFORMED ON AN UNKNOWN DATE. THIS REPORT IS FOR PATIENT TWO (2) OF TWO (2). THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW COVID-19 2.0 ASSAY PERFORMED ON AN UNKNOWN DATE. THE PATIENT WAS SYMPTOMATIC. CONFIRMATORY AND REPEAT TESTING WERE NOT PERFORMED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1630976 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. 000M904212 04571226475447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown