ELECSYS CEA
Received Dec 4, 2024 · Event occurred Nov 12, 2024
Report 1823260-2024-03522 · MDR key 20848663
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsCatalog number
11731629322
Lot number
74942507
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CA 19-9 AND ELECSYS CEA ASSAY RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS 6000 E601 MODULE. THIS MEDWATCH IS FOR THE ELECSYS CEA ASSAY. PLEASE REFER TO MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR THE ELECSYS CA 19-9 ASSAY. THE DATE OF EVENT FOR THE ELECSYS CEA ASSAY IS 19-NOV-2024. THE INITIAL RESULT WAS 23.66 NG/ML. THE REPEAT RESULT WAS 1.95 NG/ML.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE COBAS 6000 E601 MODULE IS (B)(6). THE CUSTOMER DOES NOT USE THE REQUIRED TIP/CUP FOR THE MODULE. THE MEASURING CELLS WERE OVERDUE FOR REPLACEMENT. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE WAS CONSISTENT WITH THE CUSTOMER'S USE OF UNAPPROVED PROCELL, CLEANCELL, AND TIP/CUPS. A GENERAL REAGENT PROBLEM WAS NOT PRESENT, BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGES.