ATELLICA CH CYSTATIN C_2 (CYSC_2)
Received Sep 18, 2025 · Event occurred Sep 3, 2025
Report 2432235-2025-00245 · MDR key 23088100
Device
Generic name
Test, Cystatin C
Manufacturer
Siemens Healthcare Diagnostics Inc.Model number
N/ACatalog number
11097647
Lot number
252506
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
AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ONE (1) CYSTATIN C_2 (CYSC_2) DISCORDANT PATIENT SAMPLE RESULT WAS OBTAINED WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. SIEMENS IS INVESTIGATING THE EVENT.
Description of Event or Problem
THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED A DISCORDANT CYSTATIN C_2 (CYSC_2) RESULT ON ONE (1) PATIENT SAMPLE WHEN PROCESSED ON AN ATELLICA CH 930 ANALYZER. IT IS UNKNOWN WHICH RESULT IS CORRECT OR IF ANY OF THE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYSTATIN C_2 (CYSC_2) PATIENT SAMPLE RESULT.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION (26-SEP-2025): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. SOS EVALUATED THE INFORMATION PROVIDED BY THE CUSTOMER AND THE AVAILABLE INSTRUMENT DATA. QUALITY CONTROL (QC) WAS WITHIN THE CUSTOMER¿S ACCEPTABLE RANGES. THE CAUSE OF THE EVENT IS UNKNOWN. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER EVALUATION IS REQUIRED. SECTION H6 HAS BEEN UPDATED TO REFLECT THE SOS INVESTIGATION. INITIAL MDR 2432235-2025-00245 WAS FILED ON (B)(6) 2025.