BD BBL; OXIDASE REAGENT DROPPER
Received Mar 3, 2021 · Event occurred Feb 5, 2021
Report 1119779-2021-00420 · MDR key 11406499
Device
Generic name
Discs, Strips & Reagents, Microorganism Differentiation
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
261181Catalog number
261181
Lot number
B01B211M
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
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT WAS SENT IN ERROR. THE ISSUE WAS A QC FAILURE THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD BBL¿; OXIDASE REAGENT DROPPER THERE WAS NEGATIVE RESULTS WITH P. AERUGINOSA. THE ORGANISMS WERE KNOWN OXIDASE POSITIVE. THERE WERE ALSO WEAK REACTIONS ON CAMPYLOBACTER. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD BBL¿; OXIDASE REAGENT DROPPER THERE WAS NEGATIVE RESULTS WITH P. AERUGINOSA. THE ORGANISMS WERE KNOWN OXIDASE POSITIVE. THERE WERE ALSO WEAK REACTIONS ON CAMPYLOBACTER. RESULTS WERE NOT REPORTED AND THERE WAS NO IMPACT TO PATIENT.