inforMED
MalfunctionCIC

ATELLICA CH CALCIUM (CA)

Received Aug 20, 2025 · Event occurred Jul 22, 2025

Report 2432235-2025-00217 · MDR key 22850375

Device

Generic name

Calcium

Model number

N/A

Catalog number

11097595

Lot number

252470

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

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THREE (3) CALCIUM (CA) DISCORDANT PATIENT SAMPLE RESULTS WERE OBTAINED WHEN PROCESSED ON MULTIPLE ATELLICA CH 930 ANALYZERS. IT IS UNKNOWN WHICH OF THE RESULTS 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 CALCIUM (CA) PATIENT SAMPLE RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING THREE (3) CALCIUM (CA) DISCORDANT PATIENT SAMPLE RESULTS WERE OBTAINED WHEN PROCESSED ON MULTIPLE ATELLICA CH 930 ANALYZERS. SIEMENS IS INVESTIGATING THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (30-SEP-2025): SIEMENS HEALTHCARE DIAGNOSTICS SERVICE OPERATIONS SUPPORT (SOS) CONCLUDED THE INVESTIGATION OF THE EVENT. A CUSTOMER SERVICE ENGINEER (CSE) PERFORMED ROUTINE SERVICE TASKS (ADJUSTMENTS AND PART REPLACEMENTS) ON THE ATELLICA CH 930 ANALYZER. THE TECHNICAL APPLICATION SPECIALIST (TAS) RAN MULTIPLE PRECISION STUDIES USING BOTH QUALITY CONTROL (QC) AND PATIENT SAMPLES. ALL QC PRECISION SHOWED ACCEPTABLE RESULTS AND NO EVIDENCE OF IMPRECISION. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE EVENT IS UNKNOWN. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. THE CUSTOMER IS OPERATIONAL. THE DEVICE IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. IN SECTION H6, THE INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED. INITIAL MDR 2432235-2025-00217 WAS FILED ON 20-AUG-2025.