KIT FLU A+B 30 TEST PHYSICIAN VERITOR

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER RECEIVED 3 FALSE POSITIVE TESTS WHILE RUNNING THE FLU A & B KIT. IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POSITIVE DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT?INSERT INTO THE ANALYZER WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)?3 WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER: NO, WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO. "

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR (MN# 256045), BATCH NUMBER 0021316. 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 AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST PHYSICIAN VERITOR 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THE CUSTOMER STATED THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER RECEIVED 3 FALSE POSITIVE TESTS WHILE RUNNING THE FLU A & B KIT. IS THE CUSTOMER REPORTING A FALSE POSITIVE OR FALSE NEGATIVE? FALSE POSITIVE. DID THE CUSTOMER VISUALLY INTERPRET THE RESULT OR DID THEY INSERT INTO THE ANALYZER TO DETERMINE THE RESULT?INSERT INTO THE ANALYZER. WHAT TYPE OF REFERENCE METHOD WAS USED TO CONFIRM THE RESULT (PCR, VIRAL CULTURE, ETC)? PCR. HOW MANY SPECIMENS WERE DISCREPANT (FP OR FN)? 3. WAS THE PATIENT(S) SYMPTOMATIC WHEN TESTED ON THE VERITOR PLUS ANALYZER: NO. WAS THERE ANY PATIENT IMPACT AS A RESULT OF THE FALSE RESULT? NO."