ALBP ALBUMIN BCP
Received Mar 13, 2023 · Event occurred Feb 22, 2023
Report 1823260-2023-00792 · MDR key 16531768
Device
Generic name
Bromcresol Purple Dye-binding, Albumin
Manufacturer
Roche DiagnosticsModel number
ALB BCPCatalog number
05975573190
Lot number
65252401
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
67 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
QUALITY CONTROLS WERE ACCEPTABLE ON THE DAY OF THE EVENT. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC SAMPLE HANDLING.
Additional Manufacturer Narrative
CALIBRATION DATA WAS OK.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALBP ALBUMIN BCP ON A COBAS 8000 C702 MODULE (SERIAL NUMBER (B)(4). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 82.9 G/L AND IT REPEATED AS 40.0 G/L.