inforMED
MalfunctionJGS

DIMENSION VISTA

Received Oct 8, 2025 · Event occurred Sep 15, 2025

Report 2517506-2025-00156 · MDR key 23243233

Device

Generic name

Dimension Vista V-lyte Integrated Multisensor Na+ K+ Cl-

Model number

N/A

Catalog number

10484429

Lot number

5CD807

Product problems

  • Low Test Results
  • Low Test Results

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

SIEMENS FILED THE INITIAL MDR 2517506-2025-00156 ON 08-OCT-2025. ADDITIONAL INFORMATION (12-NOV-2025): SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS EVALUATED THE INSTRUMENT DATA AND THE INFORMATION PROVIDED BY THE CUSTOMER. CALIBRATION RECOVERED ACCEPTABLY. THE REAGENT ISSUES WERE RULED OUT AS THE QUALITY CONTROL (QC) RECOVERED WITHIN THE CUSTOMER'S ACCEPTABLE RANGES AND NO ISSUES WERE OBSERVED WITH ANY OTHER PATIENT SAMPLES. THE SYSTEM ISSUES WERE RULED OUT AS THERE WERE NO ERRORS OR WARNING FOR THE SAMPLE DURING THE INITIAL RUN, WHICH RESULTED AS ERRONEOUS. THE HEMOLYSIS (H) INDEX FOR THE AFFECTED SAMPLE INDICATED THE PRESENCE OF MICRO FIBRINS/ MICRO CLOTS IN THE SAMPLE. BASED ON THE AVAILABLE INFORMATION, PRE-ANALYTICAL ISSUES CANNOT BE RULED OUT BUT THE CAUSE OF THE ERRONEOUSLY DEPRESSED RESULT CANNOT BE DETERMINED. THE CUSTOMER IS OPERATIONAL. A PRODUCT ISSUE WAS NOT IDENTIFIED. THE DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED TO REFLECT THE ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT OBTAINED ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. QUALITY CONTROL (QC) RECOVERED ACCEPTABLY ON THE DAY OF THE EVENT. SIEMENS IS EVALUATING THE EVENT.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED SODIUM (NA) RESULT ON A PATIENT SAMPLE ON A DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ONCE ON THE ORIGINAL SYSTEM AND TWICE ON AN ALTERNATE DIMENSION VISTA 500 INTELLIGENT LAB SYSTEM, AND HIGHER RESULTS WERE OBTAINED, CONSIDERED CORRECT. THE REPEAT RESULT OF 137 MMOL/L WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.