TINA-QUANT ALBUMIN GEN.2
Received Jul 22, 2025 · Event occurred Jun 19, 2025
Report 1823260-2025-02225 · MDR key 22563822
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
08056722190
Lot number
858773
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
THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFORMATION. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED THE RESULT FOR 1 PATIENT URINE SAMPLE TESTED FOR TINA-QUANT ALBUMIN GEN.2 (ALBT2) TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ON A COBAS C 503 ANALYTICAL UNIT. THE 24-HOUR ALBT2 RESULT WAS REPORTEDLY 924 MG/L (RESULT NOT MULTIPLIED BY THE TOTAL DIURESIS). THE 24-HOUR TOTAL PROTEIN RESULT WAS REPORTEDLY 284 MG/L (WHEN MULTIPLIED BY THE TOTAL 24-HOUR DIURESIS VOLUME OF 3500 ML, THE RESULT WAS 994 MG). THE ALBT2 RESULT IS OUTSIDE THE TEST'S MEASUREMENT RANGE OF 3 ¿ 400 MG/L. IT WAS NOTED THAT THE TESTS WERE ACCOMPANIED BY >TEST FLAGS; HOWEVER, THE MEASUREMENT RANGE FOR TOTAL PROTEIN IS 40 ¿ 2000 MG/L. CLARIFICATION ON THE RESULTS AND UNIT OF MEASURE HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED. THE NEPHROLOGIST QUESTIONED THE ALBT2 RESULT AS THE RESULT SHOULD BE EQUAL TO OR LESS THAN THE TOTAL PROTEIN RESULT.