KIT FLU VERITOR SYSTEM 30 TEST JAPAN
Received Mar 19, 2021 · Event occurred Feb 18, 2021
Report 3006948883-2021-00312 · MDR key 11528993
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Catalog number
256052
Lot number
UNKNOWN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY BD POINT OF CARE QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING ALLEGED FALSE POSITIVE WHEN USING THE KIT FLU VERITOR SYSTEM 30 TEST JAPAN (REF# (B)(4).). BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THERE WAS NO LOT NUMBER DOCUMENTED IN THE SUBMISSION OF THIS COMPLAINT; THEREFORE NO INTERNAL INVESTIGATIONS CAN BE PERFORMED AND THE ISSUE CANNOT BE CONFIRMED. NO RETURNS WERE RECEIVED TO INVESTIGATE. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS REPORTED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD POINT OF CARE WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH FALSE POSITIVE WHEN USING THE KIT FLU VERITOR SYSTEM 30 TEST JAPAN (REF# (B)(4).). THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.
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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE KIT FLU A+B 30 TEST PHYSICIAN VERITOR CATALOG NUMBER 256045 WHICH HAS 510K #: K112277
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU VERITOR SYSTEM 30 TEST JAPAN 5 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.