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

Catalog Number	07026706190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is: (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable elecsys afp result from the cobas e 801 analytical unit for one patient.The initial result was 1063 ng/ml.The repeat result after 1:10 dilution was 12,100 ng/ml, accompanied by a data flag.A second repeat result after 1:100 dilution was 121,000 ng/ml, accompanied by a data flag.A third repeat result after 1:400 dilution was 484,000 ng/ml, accompanied by a data flag.A fourth repeat result after a manual 1:10 dilution, and then a 1:400 dilution on the instrument, was 410,480 ng/ml.The sample was repeated after the doctor questioned it.The patient had previous results in july that were extremely high.
Additional Manufacturer Narrative
The affected patient sample was requested for investigation, but could not be provided.As the sample was not available, the investigation was unable to determine a direct root cause.

• 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: 23816117
• Report Number: 1823260-2025-05132
• Device Sequence Number: 10006411
• Product Code: LOJ
• UDI-Device Identifier: 04015630939909
• UDI-Public: 04015630939909
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981282
• 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): 02/13/2026

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 07026706190
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian