VERSACELL SAMPLE MANAGEMENT SYSTEM
Received Jun 19, 2015 · Event occurred May 27, 2015
Report 2247117-2015-00037 · MDR key 4856119
Device
Generic name
Clinical Chemistry General Purpose Laboratory Equipment
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
VERSACELL SAMPLE MANAGEMENT SYSTEMProduct problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). CCC REVIEWED THE VERSACELL LOG AND CONFIRMED THAT THE OPERATOR FRONT LOADED THE SAMPLE WITH AN INCORRECT IDENTIFICATION NUMBER. THE CAUSE OF THE INCORRECT ASSIGNMENT OF A PATIENT IDENTIFICATION NUMBER WAS DUE TO USER ERROR. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
THE OPERATOR OF A VERSACELL SAMPLE MANAGEMENT SYSTEM INCORRECTLY ASSIGNED A SAMPLE IDENTIFICATION NUMBER TO A PATIENT SAMPLE. PATIENT SAMPLE (B)(6) WAS INITIALLY LOADED INTO THE SAMPLE DRAWER, SCANNED, QUERIED, AND DELIVERED TO A DIMENSION INSTRUMENT FOR TESTING. THE OPERATOR THEN FRONT LOADED A DIFFERENT PATIENT SAMPLE AND ASSIGNED THE SAME PATIENT SAMPLE IDENTIFICATION (B)(6) TO THE SPECIMEN, WHICH WAS DELIVERED TO AN ALTERNATE DIMENSION INSTRUMENT FOR TESTING. THE INCORRECT RESULTS OF THE SPECIMEN WHICH WAS FRONT LOADED WERE REPORTED TO THE PHYSICIAN(S). THE RESULTS WERE CORRECTED AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INCORRECT ASSIGNMENT OF A PATIENT IDENTIFICATION NUMBER.