TOTAL PROTEIN GEN.2
Received Dec 11, 2023 · Event occurred Nov 16, 2023
Report 1823260-2023-03937 · MDR key 18305589
Device
Generic name
Biuret Total Protein
Manufacturer
Roche DiagnosticsCatalog number
08058652190
Lot number
ASKU
Product problems
- Output Problem
- Output Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE TP2 EXPIRATION DATE WAS NOT PROVIDED. THE ALBP REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE COBAS PRO C503 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE ALARM TRACE SHOWED ABNORMAL ASPIRATION ALARMS. THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE AND FOUND NO ISSUES WITH THE ANALYZER. THE FSE REPLACED THE SAMPLE PROBE. THE CUSTOMER HAD NO FURTHER ISSUES AFTER THE SAMPLE PROBE WAS REPLACED. THE ROOT CAUSE WAS CONSISTENT WITH A PRE-ANALYTICAL ISSUE.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH TOTAL PROTEIN GEN.2 (TP2) ASSAY AND ALBUMIN BCP (ALBP) ASSAY ON A COBAS PRO C503 ANALYZER. THIS MEDWATCH WILL APPLY TO THE TP2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ALBP ASSAY. TP2: INITIAL RESULT: 5.60 G/L. REPEAT RESULT: 75.3 G/L. ALBP: INITIAL RESULT: 4.83 G/L. REPEAT RESULT: 42.4 G/L. THE MEDICAL PERSONNEL QUESTIONED THE RESULTS AND THE SAMPLE WAS THEN REPEATED.