N LATEX CYSTATIN C
Received Jun 22, 2026 · Event occurred May 20, 2026
Report 9610806-2026-00019 · MDR key 25574683
Device
Generic name
Test, Cystatin C
Manufacturer
Siemens Healthcare Diagnostics Products GmbhCatalog number
10709554
Lot number
03446
Product problems
- Low Test Results
Patient
46 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE OBSERVATION OF DISCORDANT DEPRESSED CYSTATIN C (CYS C) RESULTS OBTAINED ON ONE PATIENT MEASURED WITH N LATEX CYSTATIN C ON THE ATELLICA NEPH 630 INSTRUMENT. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE SAME INSTRUMENT, THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULT WAS REPORTED, AS THE CORRECT RESULT, TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT DEPRESSED CYS C RESULTS.
Additional Manufacturer Narrative
AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS REGIONAL SUPPORT CENTER TO REPORT THE OBSERVATION OF DISCORDANT DEPRESSED CYSTATIN C (CYS C) RESULTS OBTAINED ON ONE PATIENT MEASURED WITH N LATEX CYSTATIN C ON THE ATELLICA NEPH 630 INSTRUMENT. SIEMENS IS INVESTIGATING. NOTE: THE N LATEX CYSTATIN C REAGENT IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER 10873631. THE 510(K) NUMBER DOCUMENTED IN SECTION G4 IS FOR THE US PRODUCT. NOTE: THE ATELLICA NEPH 630 SYSTEM IS NOT MARKETED IN THE UNITED STATES. HOWEVER, BN PROSPEC SYSTEM IS MARKETED IN THE UNITED STATES UNDER SIEMENS MATERIAL NUMBER 10463357.