ALBT2 TINA-QUANT ALBUMIN GEN.2
Received Dec 16, 2024 · Event occurred Nov 28, 2024
Report 1823260-2024-03688 · MDR key 20940176
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
04469658190
Lot number
800658
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 FOR URINE SAMPLES FROM ONE PATIENT USING A COBAS 8000 COBAS C 502 MODULE. THE CUSTOMER ALLEGED THE RESULTS DO NOT FIT THE CLINICAL PICTURE FOR THE PATIENT AS HISTORICALLY THE SAMPLES FROM THIS PATIENT PRODUCED URINE ALBUMIN RESULTS >4400 MG/L. SAMPLE 1 ON (B)(6) 2024 WAS 99.3 MG/L. SAMPLE 2 ON (B)(6) 2024 WAS 57.0 MG/L. SAMPLE 3 INITIAL RESULT WAS 61.7 MG/L. THE REPEAT RESULT FROM A DILUTION WAS 7045.4 MG/L WITH A DATA FLAG.
Additional Manufacturer Narrative
AS SAMPLE MATERIAL FROM THE PATIENT IS NOT AVAILABLE FOR FURTHER INVESTIGATION, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT WAS CONSISTENT WITH A SAMPLE-SPECIFIC ISSUE. NO GENERAL PRODUCT ISSUE WAS FOUND, AND THE PRODUCT MEETS SPECIFICATIONS.