BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR X FACTOR
Received Mar 10, 2023 · Event occurred Feb 20, 2023
Report 1024879-2023-00136 · MDR key 16523897
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton, Dickinson & Co., (bd)Model number
231729Catalog number
231729
Lot number
1333708
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR X FACTOR RESULT OF IDENTIFICATION WITH TAXO IS DISCREPANT WITH ONE BY MASS SPECTROMETRY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORT, THE RESULT OF AN IDENTIFICATION WITH TAXO IS DISCREPANT WITH THE ONE BY A MASS SPECTROMETRY.
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO DISCREPANT RESULTS WITH TAXO X FACTORS CATALOG 231729 BATCH NO.: 1333708 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO TEST PRODUCT FOR PERFORMANCE, VISUAL INSPECTION, AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.
Additional Manufacturer Narrative
DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR X FACTOR RESULT OF IDENTIFICATION WITH TAXO IS DISCREPANT WITH ONE BY MASS SPECTROMETRY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORT, THE RESULT OF AN IDENTIFICATION WITH TAXO IS DISCREPANT WITH THE ONE BY A MASS SPECTROMETRY.