BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW STREP PNEUMONIAE 22T (LFR)

    MDR report key: 18678381 · Received February 9, 2024

    Report

    Report Number
    1221359-2024-00163
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 1, 2024
    Report Date
    February 9, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED THE REQUIRED INTAKE INFORMATION TO ENABLE FURTHER INVESTIGATION, SUCH AS THE KIT'S LOT NUMBER, WAS NOT PROVIDED AND AN INVESTIGATION WAS NOT ABLE TO BE PERFORMED. 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. IN CONCLUSION, ABBOTT DIAGNOSTICS SCARBOROUGH WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUES AS NO INFORMATION WAS PROVIDED FOR INVESTIGATION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE RESULTS WITH THE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD PERFORMED ON AN UNKNOWN DATE ON AN UNKNOWN SAMPLE TYPE. NO ADDITIONAL TEST INFORMATION, INCLUDING IF THE PATIENT RESULTS WERE FALSE POSITIVE OR NEGATIVE RESULTS, WAS PROVIDED. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338860 BINAXNOW STREP PNEUMONIAE 22T (LFR) ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown