BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW STREP PNEUMONIAE 12T

    MDR report key: 20957779 · Received December 17, 2024

    Report

    Report Number
    1221359-2024-00717
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    December 1, 2024
    Report Date
    February 5, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 710-012 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 710-000. 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 PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED G4: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 710-012 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 710-000. 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 A FALSE RESULT WITH THE BINAXNOW STREP PNEUMONIAE ANTIGEN CARD WITH AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, IT IS UNABLE TO BE CONFIRMED IF THE RESULTS WERE POSITIVE OR NEGATIVE. NO ADDITIONAL TEST INFORMATION, INCLUDING CONFIRMATORY TESTING WAS PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE RESULT WITH THE BINAXNOW STREP PNEUMONIAE ANTIGEN CARD WITH AN UNKNOWN DATE WITH AN UNKNOWN SAMPLE TYPE. ALTHOUGH REQUESTED, IT IS UNABLE TO BE CONFIRMED IF THE RESULTS WERE POSITIVE OR NEGATIVE. NO ADDITIONAL TEST INFORMATION, INCLUDING CONFIRMATORY TESTING WAS PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719327 BINAXNOW STREP PNEUMONIAE 12T ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown