BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW STREP PNEUMONIAE 22T

    MDR report key: 18487402 · Received January 10, 2024

    Report

    Report Number
    1221359-2024-00049
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 23, 2023
    Report Date
    February 2, 2024
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: D1 - BRAND NAME HAS CHANGED TO BINAXNOW STREP PNEUMONIAE 22T D4 - CATALOG # HAS CHANGED TO 710-000 B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. D4-UDI:((B)(4). TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 184259 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. 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 710-000/ LOT: 184259, TEST BASE PART NUMBER 710-430 / LOT: 192976. 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 184259 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 OR THE CUSTOMER PERFORMING THE TESTING PROCEDURE INCORRECTLY.D2B:PROCODE CHANGED TO GTZ D4:UDI ADDED IN H10.

    Additional Manufacturer Narrative · 0

    B3: THE DATE PROVIDED IS AN APPROXIMATION AS THE EXACT EVENT DATE WAS NOT PROVIDED. 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 REMAINS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. H3 OTHER TEXT : SINGLE USE; DEVICE DISCARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE NEGATIVE RESULTS WITH THE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD PERFORMED ON OR BEFORE (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. ADDITIONAL TESTING WAS PERFORMED VIA A BIOFIRE TEST (PLATFORM: UNKNOWN) ON AN UNKNOWN DATE WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN UNSPECIFIED NUMBER OF FALSE NEGATIVE RESULTS WITH THE BINAXNOW STREPTOCOCCUS PNEUMONIAE ANTIGEN CARD PERFORMED ON OR BEFORE (B)(6) 2023 ON AN UNKNOWN SAMPLE TYPE. ADDITIONAL TESTING WAS PERFORMED VIA A BIOFIRE TEST (PLATFORM: UNKNOWN) ON AN UNKNOWN DATE WHICH GENERATED A POSITIVE RESULT. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114852 BINAXNOW STREP PNEUMONIAE 22T ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 184259
    287913 BINAXNOW STREP PNEUMONIAE 22T ANTISERA, ALL GROUPS, STREPTOCOCCUS SPP. GTZ ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 184259

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown