InjuryPRH
ACCELERATE PHENOTEST BC KIT
Received Apr 26, 2023 · Event occurred Mar 9, 2023
Report 3010671651-2023-00001 · MDR key 16820984
Device
Generic name
Accelerate Phenotest Bc Kit
Manufacturer
Accelerate DiagnosticsModel number
10102018Catalog number
10102018
Lot number
5793A
Product problems
- False Positive Result
- False Positive Result
Patient
76 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE ACCELERATE PHENOTEST BC KIT ALLEGEDLY HAD AN INCORRECT RESULT OF METHICILLIN-RESISTANT S. AUREUS (MRSA) AND THE PATIENT'S CENTRAL LINE WAS REMOVED AND A NEW CENTRAL LINE WAS INSERTED. THE CUSTOMER STATED THAT TESTING ON THE BD PHOENIX IDENTIFIED S. EPIDERMIDIS. THE INCORRECT RESULT HAS NOT BEEN CONFIRMED.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED BUT NOT YET COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.