TINA-QUANTALBUMIN GEN.2
Received Aug 15, 2025 · Event occurred Jul 23, 2025
Report 1823260-2025-02515 · MDR key 22817377
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
05167043190
Lot number
836567
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO GENERAL PRODUCT ISSUE WAS FOUND. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE ALBT2 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE C702 MODULE SERIAL NUMBER WAS (B)(6). THE CUSTOMER WAS HAVING QC ISSUES. THE FIELD SERVICE ENGINEER REPLACED THE RINSE TUBES, CHECKED THE NEEDLE ALIGNMENT, THE GEAR PUMP, THE NEEDLE WASHING, AND THE WASHING STATION DISPENSING. HE THEN PERFORMED SOME CHECKS, INCLUDING QC AND CHANGING THE REAGENT TRAYS, BUT THE ISSUE PERSISTED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH TINA-QUANTALBUMIN GEN.2 (ALBT2) ASSAY ON A COBAS 8000 C702 MODULE. SAMPLE 1: THE RESULTS RANGED FROM 2.8 G/DL TO 3.4 G/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS ANALYZER, RESULTING IN THE SAME VALUE RANGE. SAMPLE 2: THE RESULTS RANGED FROM 3 G/DL TO 3.6 G/DL. THE SAMPLE WAS REPEATED ON A DIFFERENT COBAS ANALYZER, RESULTING IN THE SAME VALUE RANGE. NO EXACT VALUES WERE PROVIDED. THE RESULTS' RANGE WAS FROM 0.6 G/DL TO 0.7 G/DL.