IMMULITE
Received Jun 9, 2016 · Event occurred Apr 18, 2016
Report 2247117-2016-00032 · MDR key 5709793
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. THE CUSTOMER COMPLAINED OF TIP JAM ERRORS AND SHORT SAMPLES. THE CSE EVALUATED THE INSTRUMENT AND FOUND THAT THE PROBE TIP WAS LOOSE. THE CSE TIGHTENED THE PROBE TIP AND LUBRICATED AND CLEANED THE PIPETTOR MECHANISM. THE CSE RAN LEVEL-SENSING AND PIPETTE TESTING ROUTINES. THE CSE RAN QUALITY CONTROLS AND ADJUSTMENTS, WHICH WERE ACCEPTABLE. THE CAUSE OF THE DISCORDANT, FALSELY LOW UE3 RESULTS ON PATIENT SAMPLES IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
DISCORDANT, FALSELY LOW UNCONJUGATED ESTRIOL (UE3) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN IMMULITE INSTRUMENT. THE CUSTOMER PROVIDED ONE EXAMPLE OF THE DISCORDANT UE3 RESULT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), EXCEPT FOR SAMPLE ID (B)(6). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT, RESULTING AS EXPECTED. THE REPEAT RESULT FOR SAMPLE ID (B)(6) WAS REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S) FOR THE OTHER PATIENTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW UE3 RESULTS.