DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM
Received Jul 26, 2013 · Event occurred Jun 18, 2013
Report 1226181-2013-00340 · MDR key 3248867
Device
Generic name
Clinical Chemistry System
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
DIMENSION VISTA 1500Product problems
- False Positive Result
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CUSTOMER HAD OBTAINED THE EXPECTED RESULTS UPON RETESTING THE SAMPLES ON THE SAME INSTRUMENT. THE CAUSE OF THE DISCORDANT, FALSELY LOW PSA RESULTS ON THREE PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.
Description of Event or Problem
DISCORDANT, FALSELY LOW PROSTATE SPECIFIC ANTIGEN (PSA) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON A DIMENSION VISTA 1500 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE RERUN ON THE SAME INSTRUMENT AND RESULTED HIGHER. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF THERE WAS ANY PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW PSA RESULTS.