ALBT2 TINA-QUANT ALBUMIN GEN.2
Received Mar 26, 2024 · Event occurred Mar 9, 2024
Report 1823260-2024-00915 · MDR key 18980530
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
04469658190
Lot number
ASKU
Product problems
- Insufficient Device Problem Information
- Non Reproducible Results
- Insufficient Device Problem Information
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C501 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALBT2 TINA-QUANT ALBUMIN GEN.2 (MICROALBUMIN) ON A COBAS 6000 C501 MODULE. THE SAMPLE INITIALLY RESULTED IN A MICROALBUMIN VALUE OF 32.500 MG/L AND IT REPEATED AS 11.900 MG/L.