BINAXNOW RSV WAIVED 22T

Additional Manufacturer Narrative

D4-UDI: (B)(4). ABBOTT MEDICAL AFFAIRS DECISION DETERMINED THIS FALSE NEGATIVE RESULT SHOULD BE CONSERVATIVELY REPORTED AS A MALFUNCTION. TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 817326 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 430-122/ LOT: 817326, TEST BASE PART NUMBER 430-430/ LOT: 798126. 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 817326 SHOWED THAT THE COMPLAINT RATE IS (B)(4). ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE.

Description of Event or Problem

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW RSV WAIVED 22T PERFORMED ON (B)(6) 2024 ON A NASOPHARYNGEAL SAMPLE. PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC AND THEIR SYMPTOMS WORSENED THE NEXT DAY. THEY WERE HOSPITALIZED ON (B)(6) 2024 DUE TO LOW OXYGEN WHERE CONFIRMATION TESTING WAS PERFORMED VIA AN UNKNOWN METHOD WHICH GENERATED A POSITIVE RESULT. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF TWO (2) NIGHTS AND RECEIVED SUPPLEMENTAL OXYGEN AND NEBULIZER TREATMENTS. THE PATIENT WAS TREATED WITH A DOSE OF DEXAMETHASONE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

D4-UDI:((B)(4)ABBOTT MEDICAL AFFAIRS DECISION DETERMINED THIS FALSE NEGATIVE RESULT SHOULD BE CONSERVATIVELY REPORTED AS A MALFUNCTION.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

THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WITH THE BINAXNOW RSV WAIVED 22T PERFORMED ON (B)(6)2024 ON A NASOPHARYNGEAL SAMPLE. PER THE CUSTOMER, THE PATIENT WAS SYMPTOMATIC AND THEIR SYMPTOMS WORSENED THE NEXT DAY. THEY WERE HOSPITALIZED ON (B)(6)2024 DUE TO LOW OXYGEN WHERE CONFIRMATION TESTING WAS PERFORMED VIA AN UNKNOWN METHOD WHICH GENERATED A POSITIVE RESULT. THE PATIENT WAS HOSPITALIZED FOR A TOTAL OF TWO (2) NIGHTS AND RECEIVED SUPPLEMENTAL OXYGEN AND NEBULIZER TREATMENTS. THE PATIENT WAS TREATED WITH A DOSE OF DEXAMETHASONE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.