ALBT2 TINA-QUANT ALBUMIN GEN.2
Received Aug 30, 2024 · Event occurred Aug 8, 2024
Report 1823260-2024-02515 · MDR key 20106309
Device
Generic name
Albumin Immunological Test System
Manufacturer
Roche DiagnosticsCatalog number
04469658190
Lot number
73284101
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 INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED SHOWED CALIBRATION FAILURES AND QC IMPRECISION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ALBT2 TINA-QUANT ALBUMIN GEN.2 RESULTS FOR 1 PATIENT URINE SAMPLE ON A COBAS 6000 CORE UNIT. THE INITIAL URINE ALBUMIN RESULT WAS 182.5 MG/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 2.9 MG/L ACCOMPANIED BY A FLAG INDICATING THE VALUE IS BELOW THE LINEARITY/MEASURING RANGE OF THE ASSAY. THE SAMPLE WAS REPEATED AGAIN AND THE RESULT WAS 6.1 MG/L.