DIMENSION CLINICAL CHEMSITRY SYSTEM
Received May 3, 2013 · Event occurred Mar 26, 2013
Report 1226181-2013-00199 · MDR key 3093053
Device
Generic name
Clinical Chemsitry System
Manufacturer
Siemens Healthcare Diagnostics IncModel number
RXL MAX W/HMProduct problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DISCORDANT SODIUM (NA) RESULTS WERE OBTAINED ON A DIMENSION RXL MAX INSTRUMENT FOR MULTIPLE PATIENTS. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIANS, WHO QUESTIONED THE RESULTS. THE CUSTOMER REPEATED THE SAME SAMPLES ON TWO OTHER INSTRUMENTS AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA RESULTS.
Additional Manufacturer Narrative
A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND INSTRUMENT DATA AND DETERMINED THE CAUSE OF THE DISCORDANT SODIUM RESULTS WAS UNKNOWN. THE FSE REPLACED THE MONO PUMP HOME SENSOR, RAN THE DILUENT CHECK AND QC AND DETERMINED THE QC RESULTS WERE WITHIN THE ACCEPTABLE RANGES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.