ELECSYS BRAHMS PCT
Received Jul 13, 2020 · Event occurred Jun 1, 2020
Report 1823260-2020-01671 · MDR key 10264658
Device
Generic name
Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens
Manufacturer
Roche DiagnosticsModel number
PCTCatalog number
08828679200
Lot number
466361
Product problems
- Unexpected Therapeutic Results
- Unexpected Therapeutic Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE CALIBRATION AND QC RESULTS DID NOT INDICATE ANY ISSUE WITH THE REAGENT OR ANALYZER.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS BRAHMS PCT RESULTS FOR ONE PATIENT FROM COBAS E 801 MODULE SERIAL NUMBER (B)(4) WHICH DO NOT FIT INTO CLINICAL PICTURE. THE PATIENT RECEIVES HEMODIALYSIS AND WAS TREATED SUCCESSFULLY WITH ANTIBIOTICS 2 WEEKS AGO. THE CRP RESULTS CONSTANTLY DECREASED (CURRENTLY AROUND 30 MG/DL), BUT PCT REMAINS ELEVATED AT 100 NG/ML ALL THE TIME. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN.