BD BBL¿ DRYSLIDE¿ OXIDASE
Received Mar 31, 2023 · Event occurred Mar 15, 2023
Report 2647876-2023-00010 · MDR key 16655379
Device
Generic name
See H.10
Manufacturer
Becton Dickinson Caribe Ltd.Model number
231746Catalog number
231746
Lot number
2125485
Product problems
- False Positive Result
- False Positive Result
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 FALSE POSITIVE TEST RESULTS WITH DRYSLIDE OXIDASE CATALOG 231746 BATCH NO.: 2125485 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. H3 OTHER TEXT : SEE H.10.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ DRYSLIDE¿ OXIDASE THAT THERE WAS FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH WITH FALSE POSITIVE OXIDASE TEST RESULTS. THE E COLI 25922 QUALITY CONTROL GIVES A POSITIVE REACTION IN LESS THAN 20 SECONDS (EXPECTED NEGATIVE RESULT). THE REAGENT IS STORED UNDER THE RECOMMENDED CONDITIONS AND EVEN WHEN OPENING A NEW CARD THERE IS A FLUCTUATION IN THE TEST RESPONSE. THE PROBLEMS SEEM TO BE QUITE RANDOM BUT ALSO PRESENT ON SOME CLINICAL STRAINS.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING THE BD BBL¿ DRYSLIDE¿ OXIDASE THAT THERE WAS FALSE POSITIVES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH WITH FALSE POSITIVE OXIDASE TEST RESULTS. THE E COLI 25922 QUALITY CONTROL GIVES A POSITIVE REACTION IN LESS THAN 20 SECONDS (EXPECTED NEGATIVE RESULT). THE REAGENT IS STORED UNDER THE RECOMMENDED CONDITIONS AND EVEN WHEN OPENING A NEW CARD THERE IS A FLUCTUATION IN THE TEST RESPONSE. THE PROBLEMS SEEM TO BE QUITE RANDOM BUT ALSO PRESENT ON SOME CLINICAL STRAINS.
Additional Manufacturer Narrative
COMMON DEVICE NAME: DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.