BD BBL CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM
Received Apr 13, 2021 · Event occurred Mar 24, 2021
Report 1119779-2021-00660 · MDR key 11659348
Device
Generic name
Gram Negative Identification Panel
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
245000
Lot number
0066303
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
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY THIS COMPLAINT IS FOR THE MIS-IDENTIFICATION OF KLEBSIELLA VARIICOLA AS KLEBSIELLA PNEUMONIAE. THERE ARE NO CLAIMS FOR THIS ORGANISM AS IT IS NOT IN THE PHOENIX ID DATABASE. THIS COMPLAINT IS NOT CONFIRMED. A REVIEW OF COMPLAINTS REVEALED NO ADDITIONAL COMPLAINTS ON THIS CATCH. A REVIEW OF QUALITY NOTIFICATIONS REVEALED THERE WERE NO QUALITY NOTIFICATIONS NOTED ON THIS BATCH.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD BBL¿ CRYSTAL¿ ENTERIC/NONFERMENTER ID SYSTEM KLEBSIELLA VARIICOLA WAS MISIDENTIFIED AS K PNEUMONIAE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS UNEXPECTED ID OF KLEBSIELLA VARIICOLA AS K PNEUMONIAE NO FURTHER FOLLOW UP NEEDED, CUSTOMER WAS ADVISED THAT K VARIICOLA IS NOT IN DATABASE TAXA LIST FOR IDENTIFICATION.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD BBL¿ CRYSTAL¿ ENTERIC/NONFERMENTER ID SYSTEM KLEBSIELLA VARIICOLA WAS MISIDENTIFIED AS K PNEUMONIAE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS UNEXPECTED ID OF KLEBSIELLA VARIICOLA AS K PNEUMONIAE NO FURTHER FOLLOW UP NEEDED, CUSTOMER WAS ADVISED THAT K VARIICOLA IS NOT IN DATABASE TAXA LIST FOR IDENTIFICATION.