IMMULITE 2000
Received Jan 3, 2018 · Event occurred Dec 7, 2017
Report 2247117-2018-00001 · MDR key 7162122
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 THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CCC SPECIALIST REVIEWED ADJUSTMENT GUIDELINES WITH THE CUSTOMER. THE CUSTOMER READJUSTED THE KIT LOT WITH A FRESH SET OF ADJUSTORS AND ADJUSTMENT SLOPE RETURNED TO HISTORICAL PERFORMANCE AND QUALITY CONTROL (QC) RESULTED IN RANGE. THE CAUSE FOR THE CUSTOMER TO REPORT PATIENT RESULTS WHILE QC WAS OUT OF RANGE IS DUE TO USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.
Description of Event or Problem
DISCORDANT THYROID STIMULATING HORMONE (TSH) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN IMMULITE 2000 INSTRUMENT WHEN QUALITY CONTROL (QC) LEVEL 1 WAS OUT OF RANGE LOW. AND THIS IS DOCUMENTED IN THE DATA LOGS. THESE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULTS. THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE IMMULITE 2000 INSTRUMENT. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT TSH RESULTS.