IMMULITE
Received Apr 6, 2016 · Event occurred Mar 15, 2016
Report 2247117-2016-00022 · MDR key 5550089
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE DISCORDANT RESULTS WERE OBTAINED WHEN THE OPERATOR SWITCHED THE WATER AND PROBE WASH LINES. THE CUSTOMER SWITCHED THE LINES BACK TO THEIR RESPECTIVE POSITIONS. THE CCC SPECIALIST INSTRUCTED THE CUSTOMER TO RUN DECONTAMINATION TWICE BEFORE REPEATING QUALITY CONTROLS. THE CUSTOMER THEN PRIMED THE SYRINGES AND WATER PUMP BY PERFORMING A DECONTAMINATION DIAGNOSTIC PROCEDURE. THE CUSTOMER RAN QUALITY CONTROLS AND PATIENT SAMPLES, WHICH WERE ACCEPTABLE. THE CAUSE OF THE DISCORDANT RESULTS ON PATIENT SAMPLES WAS DUE TO THE USER ERROR. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
DISCORDANT RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). ALL THE DISCORDANT RESULTS WERE LESS THAN ASSAY LIMITS. AFTER TROUBLESHOOTING, THE CUSTOMER REPEATED THE SAMPLES AND THE RESULTS WERE ACCEPTABLE. IT IS UNKNOWN IF THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT PATIENT RESULTS.