TOTAL PROTEIN GEN.2
Received Mar 17, 2026 · Event occurred Feb 20, 2026
Report 1823260-2026-00950 · MDR key 24619910
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
08058652190
Lot number
88321701
Product problems
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. THE ALARM TRACE DATA SHOWS MULTIPLE ABNORMAL ASPIRATION, SAMPLE SHORT, AND ABNORMAL CELL BLANK ALARMS. THE CUSTOMER USED A SAMPLE VOLUME OF 4.5 ML INSTEAD OF THE RECOMMENDED 5 ML. NO ISSUES WERE OBSERVED ON THE REACTION MONITOR DATA. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE ULTRASONIC MIXER (USM), THE SAMPLE PROBE, AND THE RINSE WATER, BASIC WASH, ACID WASH, AND BLANK WATER IN THE CUVETTE RINSE STATION. INSTRUMENT PERFORMANCE TESTING WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TOTAL PROTEIN GEN.2 (TP2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.41 G/L. THE REPEAT RESULT WAS 68.1 G/L.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A COMBINATION OF PREANALYTICAL SAMPLE-HANDLING ISSUES AND MISADJUSTMENTS TO THE ULTRASONIC MIXER AND RINSE LEVELS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.