BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW STREP PNEUMONIAE 12T

    MDR report key: 21713289 · Received March 27, 2025

    Report

    Report Number
    1221359-2025-00149
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    November 14, 2024
    Report Date
    May 30, 2025
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GTZ
    UDI-DI
    10811877011078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 710-012 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.

    Additional Manufacturer Narrative · 0

    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. UPON INVESTIGATION COMPLETION AND FURTHER EVENT REVIEW, THE REPORTED EVENT SHOULD HAVE BEEN CLASSIFIED AS A FALSE POSITIVE RESULT INITIALLY WHICH IS NOT CONSIDERED TO BE A REPORTABLE EVENT. CORRECTION: B5 - DESCRIBE EVENT OR PROBLEM. H6 - MEDICAL DEVICE PROBLEM CODE. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 836680 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL. 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 710-012 /LOT: 836680, DEVICE PART NUMBER 710-430R/ LOT: 820062. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE POSITIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 836680 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 SPECIFIC PATIENT SAMPLES.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW STREP PNEUMONIAE TEST FOR 4 TESTS ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST ONE(1) OF FOUR(4) PERFORMED ON (B)(6) 2024. THE CONSUMER REPORTED CONFLICTING RESULTS WITH THE BINAXNOW STREP PNEUMONIAE TEST PERFORMED ON (B)(6) 2024 ON AN UNKNOWN SAMPLE TYPE. THE CUSTOMER REPORTED THAT WHEN THE TEST WAS VISUALLY READ THE RESULT APPEARED NEGATIVE, HOWEVER WHEN READ WITH THE DIGIVAL READER THE RESULT WAS POSITIVE. ADDITIONAL TESTING (UNKNOWN NON-ABBOTT BRANDS) WAS PERFORMED WHICH GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING IMPACT, TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW STREP PNEUMONIAE TEST FOR 4 TESTS ON (B)(6) 2024. THIS MFR. REPORT ADDRESSES TEST ONE(1) OF FOUR(4) PERFORMED ON (B)(6) 2024. THE CONSUMER REPORTED FALSE POSITIVE RESULTS WITH THE BINAXNOW STREP PNEUMONIAE TEST PERFORMED ON (B)(6) 2024 ON AN UNKNOWN SAMPLE TYPE. THE CUSTOMER REPORTED THAT WHEN THE TEST WAS VISUALLY READ THE RESULT APPEARED NEGATIVE, HOWEVER WHEN READ WITH THE DIGIVAL READER THE RESULT WAS POSITIVE. ADDITIONAL TESTING (UNKNOWN NON-ABBOTT BRANDS) WAS PERFORMED WHICH GENERATED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT INFORMATION, INCLUDING IMPACT, TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530288 BINAXNOW STREP PNEUMONIAE 12T ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 836680 10811877011078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown