KIT FLU A+B 30 TEST HOSPITAL VERITOR
Received Feb 16, 2021 · Event occurred Jan 25, 2021
Report 3006948883-2021-00232 · MDR key 11335185
Device
Generic name
Devices Detecting Influenza A, B, And C Virus Antigens
Manufacturer
Bd Rapis Diagnostics (suzhou) Co. Ltd.Model number
256041Catalog number
256041
Lot number
9361700
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT FLU A+B 30 TEST HOSPITAL VERITOR (MATERIAL # 256041), BATCH NUMBER 9361700. 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 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 HOSPITAL VERITOR 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT.PATIENT IMPACT.
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. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING KIT FLU A+B 30 TEST HOSPITAL VERITOR 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. A PCR TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THE CUSTOMER STATED RESULTS WERE REPORTED OUT, BUT THERE WAS NO REPORT OF PATIENT IMPACT. PATIENT IMPACT.