inforMED
MalfunctionMKW

ADVIA CENTAUR XP CYCLOSPORINE (CSA) ASSAY

Received Apr 17, 2018 · Event occurred Jan 15, 2018

Report 1219913-2018-00130 · MDR key 7436765

Device

Generic name

Cyclosporine Assay

Model number

N/A

Catalog number

10335448

Lot number

77934031

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CYCLOSPORINE (CSA) RESULTS IS UNKNOWN. SIEMENS REVIEWED THE CUSTOMER DATA. THE OVERALL BIAS IS IN LINE WITH WHAT IS EXPECTED IN THE ADVIA CENTAUR CYCLOSPORINE IFU (INSTRUCTIONS FOR USE), 10629836_EN REV, K, 2017-12 ACCURACY/METHOD COMPARISON SECTION WITH TANDEM-MS. IN ADDITION THE ADVIA CENTAUR CYCLOSPORINE ASSAY DOES NOT HAVE A CLAIM TO BE COMPARABLE TO ANY OTHER METHODS OR PLATFORMS. THE LC/MS/MS METHODS ALSO DO NOT SEEM TO BE IN ALIGNMENT WITH EACH OTHER AND DEMONSTRATE VARIABILITY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE IFU STATES IN THE LIMITATIONS SECTION: "ALWAYS USE MEASUREMENTS OF CSA IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION."

Description of Event or Problem

A HIGH ADVIA CENTAUR XP CYCLOSPORINE (CSA) RESULT WAS OBTAINED ON A PATIENT SAMPLE DURING A METHOD COMPARISON. THE CYCLOSPORINE RESULTS WERE HIGHER THAN THE LC-MS/MS METHODS. THE PATIENT SAMPLE WAS TESTED ON THE LC-MS/MS AT TWO LABORATORIES. THE INITIAL RESULTS WERE REPORTED AND QUESTIONED BY ONE PHYSICIAN. CORRECTED RESULTS WERE REPORTED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CYCLOSPORINE (CSA) RESULTS.