ELECSYS AFP
Received Jul 11, 2025 · Event occurred Jun 17, 2025
Report 1823260-2025-02126 · MDR key 22484085
Device
Generic name
Kit, Test,alpha-fetoprotein For Testicular Cancer
Manufacturer
Roche DiagnosticsCatalog number
09015124190
Lot number
801769
Product problems
- High Test Results
- Contamination /Decontamination Problem
- Non Reproducible Results
- High Test Results
- Contamination /Decontamination Problem
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM BASED ON THE INFORMATION PROVIDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 3 PATIENTS' SAMPLES TESTED WITH ELECSYS ALPHA-FETOPROTEIN (AFP) ASSAY ON A COBAS 8000 E 801 ANALYZER. SAMPLE 1: INITIAL RESULT: 23.3 NG/ML. 1ST REPEAT RESULT: 2.5 NG/ML. 2ND REPEAT RESULT: 2.49 NG/ML. SAMPLE 2: INITIAL RESULT: 22.9 NG/ML. 1ST REPEAT RESULT: 2.79 NG/ML. 2ND REPEAT RESULT: 2.77 NG/ML. SAMPLE 3: INITIAL RESULT: 12.7 NG/ML. 1ST REPEAT RESULT: 1.7 NG/ML. 2ND REPEAT RESULT: 1.69 NG/ML. THE INITIAL RESULTS DID NOT MATCH THE PATIENTS' CLINICAL DIAGNOSIS, AND THE SAMPLES WERE REPEATED. THE 2ND REPEAT RESULTS WERE OBTAINED FROM ANOTHER E 801. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.
Additional Manufacturer Narrative
THE AFP REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE COBAS E 801 MODULE SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER CHECKED THE INSTRUMENT AND FOUND THAT THE SAMPLE PROBE WAS NOT CLEAN. HE REPLACED THE SAMPLE PROBE. THE INVESTIGATION IS ONGOING.