KIT FLU A+B 30 TEST PHYSICIAN VERITOR

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A MIX UP WITH THE COVID (RV REAGENT D) AND FLU A&B CARTIDGE IN THE LABORATORY WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR AND 5 FALSE POSITIVE RESULTS WERE OBTAINED. CUSTOMER STATED THAT THE COVID REAGENT AND FLU REAGENT LOOK IDENTICAL AND IT WAS HARD TO DISTINGUISH THE TWO. THE PATIENTS WERE TOLD THEY WERE POSITIVE FOR FLU A, HOWEVER, CUSTOMER WAS UNSURE IF THEY WERE TREATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED AND REPORTED THAT THERE WAS A MIX UP WITH THE COVID (RV REAGENT D) AND THE FLU A&B CARTRIDGE. CUSTOMER SAID THAT EVERY TIME SHE USED THE REAGENT WITH THE FLU CARTRIDGE IT CAUSED THE FLU A TO BE POSITIVE EVERY TIME. CUSTOMER GOT 5 ERRONEOUS RESULTS.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A MIX UP WITH THE COVID (RV REAGENT D) AND FLU A&B CARTIDGE IN THE LABORATORY WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR AND 5 FALSE POSITIVE RESULTS WERE OBTAINED. CUSTOMER STATED THAT THE COVID REAGENT AND FLU REAGENT LOOK IDENTICAL AND IT WAS HARD TO DISTINGUISH THE TWO. THE PATIENTS WERE TOLD THEY WERE POSITIVE FOR FLU A, HOWEVER, CUSTOMER WAS UNSURE IF THEY WERE TREATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED AND REPORTED THAT THERE WAS A MIX UP WITH THE COVID (RV REAGENT D) AND THE FLU A&B CARTRIDGE. CUSTOMER SAID THAT EVERY TIME SHE USED THE REAGENT WITH THE FLU CARTRIDGE IT CAUSED THE FLU A TO BE POSITIVE EVERY TIME. CUSTOMER GOT 5 ERRONEOUS RESULTS.

Additional Manufacturer Narrative

H.6. INVESTIGATION: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MATERIAL # 256045), BATCH NUMBER UNKNOWN. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED BECAUSE A BATCH NUMBER WAS NOT PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. CUSTOMER REPORTED THAT THERE WAS A MIX UP IN THEIR LAB WITH THE COVID REAGENT AND THE FLU A&B CARTRIDGE. THEY REALIZED THEY WERE USING THE WRONG PRODUCTS TOGETHER WHEN THEY KEPT GETTING A POSITIVE FLU A RESULT ON EVERY TEST. THE CUSTOMER NOTIFIED THE DOCTOR KNOW ABOUT THE MISTAKE MADE IN THE LAB. THE ROOT CAUSE WAS TRACED TO AN ¿UNINTENDED USER ERROR CAUSED OR CONTRIBUTED TO THE EVENT¿. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H.10.