TOTAL PROTEIN/TOTAL PROTEIN STAT
Received Mar 22, 2023 · Event occurred Feb 20, 2023
Report 1823260-2023-00927 · MDR key 16589552
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Roche DiagnosticsModel number
NACatalog number
03183734190
Lot number
65252101
Product problems
- Low Test Results
- Low Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
QUALITY CONTROL RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED PRECISION TESTING WHICH WAS WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE TP2 (TOTAL PROTEIN GEN.2) ASSAY ON A COBAS 8000 COBAS C 502 MODULE, SERIAL NUMBER (B)(6). THE SAMPLE INITIALLY RESULTED IN A TP2 VALUE OF 0.02 G/DL. ON (B)(6) 2023, THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN TP2 VALUES OF 6.27 G/DL AND 6.20 G/DL. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER CHECKED THE SAMPLE PROBE AND THE WATER LEVEL OF THE SAMPLE PROBE WASHING. NO ISSUES WERE FOUND. THE ISSUE DID NOT RE-OCCUR. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.