ALB2 ALBUMIN GEN.2
Received May 22, 2023 · Event occurred Apr 25, 2023
Report 1823260-2023-01705 · MDR key 16975586
Device
Generic name
Bromcresol Green Dye-binding, Albumin
Manufacturer
Roche DiagnosticsModel number
C701Catalog number
05166861190
Lot number
67564801
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ALBUMIN (ALB2) ASSAY ON A COBAS 8000 COBAS C701 MODULE. DISCREPANT RESULT FOR ONE SAMPLE WAS PROVIDED AND THE PATIENT'S SAMPLE WAS A PLASMA SAMPLE. INITIAL RESULT: 2.93 G/DL. REPEAT RESULT: 3.45 G/DL. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY. QC HAD DROPPED OUT BY 3SD PROMPTING THE RERUN OF THE SAMPLE. THE RERUN RESULT WAS DEEMED TO BE CORRECT. A REPORT WITH THE CORRECTED RESULTS FOR THE 3 SAMPLES WAS REPORTED OUTSIDE THE LABORATORY. THE ALB2 REAGENT LOT NUMBER WAS 67564801 WITH AN EXPIRATION DATE OF 29-FEB-2024.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) REPLACED THE REAGENTS MIXERS, THE DEGASSER TANK AND THE WATER BATH DEGASSER. THE FSE DID SERVICE DIAGNOSTICS CHECK AND IT WAS ACCEPTABLE. QC WAS PERFORMED AND WAS ACCEPTABLE. INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE SERVICE ACTIONS (REPLACING THE REAGENTS MIXERS, THE DEGASSER TANK AND THE WATER BATH DEGASSER) RESOLVED THE ISSUE.