BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW STREP PNEUMONIAE 22T (LFR)

    MDR report key: 22509166 · Received July 15, 2025

    Report

    Report Number
    1221359-2025-00321
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    January 1, 2025
    Report Date
    August 1, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT NO TESTING WAS PERFORMED USING THE BINAXNOW STREP PNEUMONIAE AND WAS REPORTED ERRONEOUSLY. AS THERE IS NO ALLEGATION AGAINST THE BINAXNOW STREP PNEUMONIAE, NO INVESTIGATION WILL BE NEEDED. B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 710-100 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 710-000.

    Additional Manufacturer Narrative · 0

    B3: THE DATE INDICATED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 710-100 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 710-000. THE REMAINDER OF THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED PENDING COMPLETION, OR UPON RECEIPT OF NEW INFORMATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF CONFLICTING RESULTS BETWEEN A VISUAL READ AND AN INSTRUMENT READ (DIGIVAL) OF BINAXNOW STREP PNEUMONAIE TESTS. THE SAMPLE TYPE IS UNKNOWN. IT IS UNKNOWN WHETHER CONFIRMATION TESTING WAS PERFORMED, HOWEVER THE CUSTOMER REPORTS THAT THERE WAS A NEGATIVE CLINICAL PICTURE IN RELATION TO EACH TEST AND IS CONSIDERING THE RESULTS FALSE POSITIVES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNKNOWN QUANTITY OF CONFLICTING RESULTS BETWEEN A VISUAL READ AND AN INSTRUMENT READ (DIGIVAL) OF BINAXNOW STREP PNEUMONAIE TESTS. THE SAMPLE TYPE IS UNKNOWN. IT IS UNKNOWN WHETHER CONFIRMATION TESTING WAS PERFORMED. HOWEVER, THE CUSTOMER REPORTS THAT THERE WAS A NEGATIVE CLINICAL PICTURE IN RELATION TO EACH TEST AND IS CONSIDERING THE RESULTS FALSE POSITIVES. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION INCLUDING PATIENT TREATMENT AND OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1771785 BINAXNOW STREP PNEUMONIAE 22T (LFR) ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown