BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW STREP PNEUMONIAE 22T (LFR)

    MDR report key: 22079355 · Received May 23, 2025

    Report

    Report Number
    1221359-2025-00244
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 16, 2025
    Report Date
    June 13, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GTZ
    UDI-DI
    10811877011085
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 883463 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SAMPLES. 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 710-100 / LOT 883463 AND DEVICE PART NUMBER 710-430R/ LOT 870004. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 883463 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 HAVE POSSIBLY BEEN RELATED TO THE SPECIFIC PATIENT SAMPLE.

    Additional Manufacturer Narrative · 0

    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 A FALSE NEGATIVE RESULT WITH THE BINAXNOW STREP PNEUMONIAE 22T ASSAY PERFORMED ON (B)(6) 2025, ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTS OF A PCR AND A CULTURE WERE PERFORMED AND RETURNED POSITIVE RESULTS. NO ADDITIONAL INFORMATION, INCLUDING PATIENT INFORMATION, TREATMENT, OR OUTCOME, WERE PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW STREP PNEUMONIAE 22T ASSAY PERFORMED ON (B)(6) 2025 ON AN UNKNOWN SAMPLE TYPE. CONFIRMATION TESTS OF A PCR AND A CULTURE WERE PERFORMED AND RETURNED POSITIVE RESULTS. NO ADDITIONAL INFORMATION, INCLUDING PATIENT INFORMATION, TREATMENT, OR OUTCOME, WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070135 BINAXNOW STREP PNEUMONIAE 22T (LFR) ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 883463 10811877011085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown