TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION
Received Mar 19, 2026 · Event occurred Feb 28, 2026
Report 1823260-2026-01003 · MDR key 24641016
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
04469658190
Lot number
ASKU
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE DETERGENT VOLUME WAS LOWER THAN SPECIFIED AND ADJUSTED IT. THE CUSTOMER HAS NOT COMPLAINED OF ANY FURTHER ISSUES. BASED ON THE INFORMATION PROVIDED, THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT URINE SAMPLE TESTED FOR TINA-QUANT ALBUMIN GEN.2 - URINE APPLICATION ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS <2.6 MG/L. THE REPEAT RESULT WAS 3.5 MG/L. THE SAMPLE WAS REPEATED WITH A RESULT OF 301 MG/L. ON (B)(6) 2026, THE SAMPLE WAS REPEATED WITH A RESULT OF 36.1 MG/L. THE SAMPLE WAS REPEATED FURTHER WITH RESULTS OF <0.9 MG/L, < 0.9 MG/L, <0.7 MG/L AND < 2.9 MG/L.
Additional Manufacturer Narrative
THE C501 MODULE SERIAL NUMBER WAS (B)(6).