SOFIA INFLUENZA A+B FIA

Additional Manufacturer Narrative

THE CLINICIAN REPORTED THAT SOFIA INFLUENZA A+B FIA, LOT #703664, WAS USED FOR TESTING PERFORMED AT THE (B)(6) CLINIC. NO TESTS WERE RETURNED FROM THE CLINIC BECAUSE THE REMAINING TESTS IN THE KIT WERE USED. TWO DIFFERENT ANALYZERS WERE USED AT THE CLINIC. THE CLINIC PROVIDED THE DATA LOGS TO QUIDEL FOR SERIAL (B)(4) A SUMMARY OF THE DATA LOG REVIEW AND INVESTIGATION IS NOTED BELOW: DATA LOGS: CALIBRATION AND EXTERNAL QC TESTING WERE PERFORMED ON BOTH ANALYZERS WITH PASSING RESULTS. NO RELEVANT ERROR CODES WERE NOTED. ONLY SOFIA INFLUENZA A+B FIA CASSETTE LOT #126966 WAS USED DURING THE SPECIFIED TIMEFRAME AND DATE PROVIDED BY THE CLINIC. THIS CASSETTE LOT # WAS USED IN KIT LOT #703733, NOT KIT LOT #703664 (THE KIT LOT # REPORTED BY THE CLINIC). KIT LOT #703733 WAS RELEASED ON 11/09/2017, EXPIRATION 09/25/2019. KIT LOT #703664 WAS RELEASED ON 12/01/2017, EXPIRATION 10/23/2019 BOTH DATA LOGS REVEALED POSITIVE AND NEGATIVE RESULTS FOR TESTING PERFORMED ON (B)(6) 2018. NO UNUSUAL TEST RESULTS WERE NOTED. QUIDEL QC TESTING: BOTH KIT LOT NUMBERS (703733 AND 703664) WERE TESTED WITH NEGATIVE, FLU A LOW LEVEL QC STANDARD, AND FLU B LOW LEVEL QC STANDARD. ALL RESULTS WERE ACCEPTABLE. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR BOTH KIT LOT NUMBERS, AND NO FALSE NEGATIVE RESULTS WERE NOTED. A COMPLAINT ANALYSIS FOR BOTH KIT LOTS WAS PERFORMED, AND NO TREND FOR FALSE NEGATIVE RESULTS WAS NOTED. CONCLUSION: QUIDEL WAS UNABLE TO DUPLICATE THE COMPLAINT IN OUR TESTING, AND NO UNUSUAL RESULTS OR DATA WERE NOTED IN THE DATA LOGS FOR BOTH ANALYZERS.

Description of Event or Problem

ON (B)(6) 2018, THE CHIEF MEDICAL OFFICER OF (B)(6) HEALTHCARE CONTACTED QUIDEL REGARDING A PATIENT WHO WAS TESTED FOR INFLUENZA WITH THE SOFIA INFLUENZA A+B FIA. THE TESTING OCCURRED ON (B)(6) 2018 AT THE (B)(6) IMMEDIATE CARE FACILITY ((B)(6) LOCATION). THE TEST RESULTS WERE NEGATIVE FOR INFLUENZA A AND INFLUENZA B. ON (B)(6) 2018, THE PATIENT WAS LIFE-FLIGHTED TO A HOSPITAL AND TESTED POSITIVE FOR INFLUENZA. ON (B)(6) 2018, THE PATIENT PASSED AWAY AT THE HOSPITAL.