BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR VX FACTOR
Received Mar 10, 2023 · Event occurred Feb 20, 2023
Report 1024879-2023-00135 · MDR key 16523898
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton, Dickinson & Co., (bd)Model number
231731Catalog number
231731
Lot number
2056559
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
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO DISCREPANT RESULTS WITH TAXO VX FACTORS CATALOG 231731 BATCH NO.: 2056559 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. IT IS RECOMMENDED TO USE MICROORGANISM STATED ON THE PRODUCT INSERT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.
Description of Event or Problem
IT WAS REPORTED THAT BD BBL¿ TAXO¿ DIFFERENTIATION DISCS FOR VX FACTOR RESULTS OF IDENTIFICATION WITH TAXO IS DISCREPANT WITH ONE BY A MASS SPECTROMETRY. NO TREATMENT WAS REPORTED. 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
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 VX FACTOR RESULTS OF IDENTIFICATION WITH TAXO IS DISCREPANT WITH ONE BY A MASS SPECTROMETRY. NO TREATMENT WAS REPORTED. 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.