IMMULITE
Received Feb 2, 2017 · Event occurred Jan 8, 2017
Report 2247117-2017-00011 · MDR key 6298022
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATING THE INSTRUMENT, THE CSE DETERMINED THAT THE INSTRUMENT HAD ONGOING SYRINGE ERRORS. THE CSE REPLACED THE SYRINGE PUMP AND THE ISSUE RESOLVED. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE SERVICE REPORT AND STATED THAT THE FAULTY SYRINGE PUMP MAY HAVE CAUSED THE DISCORDANT RESULTS DUE TO THE INACCURATE DISPENSE AND ASPIRATION VOLUMES. QUALITY CONTROLS AND PATIENT SAMPLES HAVE BEEN RUNNING AS EXPECTED AFTER THE TROUBLESHOOTING WAS PERFORMED BY THE CSE. THE CAUSE OF THE DISCORDANT PROGESTERONE RESULTS ON TWO PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO THE SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.
Description of Event or Problem
DISCORDANT PROGESTERONE RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN IMMULITE INSTRUMENT. THE SAMPLES WERE REPEATED TWICE ON THE SAME INSTRUMENT, RESULTING HIGHER ON THE FIRST REPEAT AND LOWER ON THE SECOND REPEAT RUN. ALL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE PHYSICIAN(S) ACCEPTED THE HIGHER PROGESTERONE RESULTS FOR BOTH PATIENTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PROGESTERONE RESULTS.