MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AFP; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Catalog Number	09015124190
Medical Device Problem Codes	High Test Results (2457); Contamination /Decontamination Problem (2895); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
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.

• Brand Name: ELECSYS AFP
• Common Device Name: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22484085
• Report Number: 1823260-2025-02126
• Device Sequence Number: 8669204
• Product Code: LOJ
• UDI-Device Identifier: 07613336172025
• UDI-Public: 07613336172025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K220176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 09015124190
• Device Lot Number: 801769
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown