DIMENSION VISTA
Received Sep 28, 2016 · Event occurred Sep 5, 2016
Report 2517506-2016-00325 · MDR key 5982807
Device
Generic name
Cyclosporine Flex® Reagent Cartridge
Manufacturer
Siemens Healthcare Diagnostics Inc - GlasgowCatalog number
K4089 SMN 10445139
Lot number
16075AB
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED CSA RESULT IS UNKNOWN. SIEMENS HEADQUARTERS SUPPORT CENTER HAS COMPLETED THE INVESTIGATION AND DETERMINED THAT THE QC FAILURE MATCHED THE PATIENT RECOVERY FAILURE FOR THIS DATE. THE ISSUE WAS RESOLVED BY REPEAT WITH A NEW CALIBRATION ON AN ALTERNATE LOT. NO RETURNED SAMPLE OR REAGENT WAS AVAILABLE FOR EVALUATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
A FALSELY DEPRESSED CYCLOSPORIN A (CSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION VISTA INSTRUMENT. THE RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AFTER AN OUT OF RANGE QC RESULT WAS OBSERVED. THE SAMPLE WAS REPEATED AND A HIGHER RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED ON THE BASIS OF THE FALSELY DEPRESSED (CSA) RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED (CSA) RESULT.