ATELLICA CH
Received Feb 24, 2025 · Event occurred Jan 28, 2025
Report 2432235-2025-00067 · MDR key 21444007
Device
Generic name
Atellica Ch Tacrolimus
Manufacturer
Siemens Healthcare Diagnostics Inc.Catalog number
SMN 11097542
Lot number
140193
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING DISCORDANT TACROLIMUS (TACR) RESULTS OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER AND INSTRUMENT DATA FILES. QUALITY CONTROL (QC) AND CALIBRATION RECOVERED WITHIN THE CUSTOMER¿S EXPECTED RANGES ON THE DAY OF THE EVENT. THE INSTRUMENT DATA INDICATES NO ISSUES WITH THE TACROLIMUS (TACR) ASSAY OR THE ATELLICA CH 930 ANALYZER. THE CUSTOMER STATED THAT THERE WAS AN ERROR IN THE PREPARATION OF THE SAMPLES DURING THE PRE-ANALYTICAL PHASE. THE CAUSE OF THE EVENT WAS CONSISTENT WITH USER ERROR. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.
Description of Event or Problem
THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED DISCORDANT TACROLIMUS (TACR) RESULTS ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THE CUSTOMER DECLINED TO PROVIDE THE PATIENT SAMPLE DATA. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TACROLIMUS (TACR) RESULTS.