ALBT2 TINA-QUANT ALBUMIN GEN.2
Received Jan 6, 2025 · Event occurred Dec 17, 2024
Report 1823260-2025-00040 · MDR key 21085254
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
05167043190
Lot number
75810301
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION DATA SHOWED SOME DEGREE OF CALIBRATION FAILURES. QUALITY CONTROL DATA SHOWED RECOVERY ISSUES. HARDWARE CHECK DATA SHOWED SOME ISSUES WITH PIPETTING PRECISION AND MIXING. ALARM TRACE DATA SHOWED PRESSURE SENSOR ERRORS AND FAILED SAMPLE PROBE WASH ERRORS. THE SAMPLE PROBES WERE EXCHANGED. THE INVESTIGATION COULD NOT IDENTIFY A SPECIFIC ROOT CAUSE. THE ISSUE IS CONSISTENT WITH A MIXTURE OF HARDWARE ISSUES AS WELL AS SAMPLE CLOT ISSUES.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE FIRST C 702 ANALYZER IS (B)(6) AND THE SERIAL NUMBER OF THE SECOND C 702 ANALYZER IS (B)(6). THE PROVIDED CALIBRATION DATA SHOWED SOME DEGREE OF CALIBRATION FAILURES. THE PROVIDED QUALITY CONTROL DATA SHOWED SOME QC RECOVERY ISSUES. A HARDWARE CHECK TEST WAS PERFORMED AND SHOWED ISSUES WITH PRECISION FOR ANOTHER TEST. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT CEREBROSPINAL FLUID SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 ON TWO COBAS 8000 C702 MODULE ANALYZERS. THE SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 378 MG/L WHEN TESTED ON THE FIRST C 702 ANALYZER. THE SAMPLE WAS REPEATED ON THE SECOND C 702 ANALYZER, RESULTING IN A VALUE OF 225 MG/L. THE 225 MG/L VALUE WAS REPORTED TO THE PHYSICIANS.