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

Catalog Number	07026706190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample was received for investigation, where it was measured on a cobas e801, obtaining a result of 82.2 iu/ml (99.462 ng/ml), confirming the elecsys result generated by the customer.On (b)(6) 2025, the sample was tested using a competitor method (snibe) at an external laboratory, resulting in the following: 1st measurement: 87.4 iu/ml.2nd measurement: 86.3 iu/ml.Snibe reference range: = 6.05 iu/ml.The snibe results were consistent with the elecsys results.No interference was identified during peg precipitation experiments at the customer site.A general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
The e801 analytical unit serial number was (b)(6).The sample showed no hemolysis or lipid.The customer performed polyethylene glycol (peg) 6000 precipitation experiment, and the recovery rate was normal with no abnormal fluctuations.The afp results were as follows: 98.0 ng/ml with no dilution.98.5 ng/ml with a dilution factor of 1:2.97.9 ng/ml with a dilution factor of 1:5.96.3 ng/ml with a dilution factor of 1:10.53.5 ng/ml obtained twice.The calibration and qc were acceptable.The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results not matching the patient's clinical picture for 1 patient sample when tested with elecsys alpha 1-fetoprotein (afp) assay on a cobas e801 analytical unit.Initial result: 91.3 ng/ml.The customer questioned the initial result as it did not match the patient's clinical diagnosis and repeated the sample.No questionable result was reported outside the laboratory.Afp result on wako chemiluminescence: 2.7 ng/ml, and this result was considered normal (reference range: 0-7 ng/ml).Afp-l3/afp: <0.5 % (reference range: 0-9.99).Pivka result on fuji chemiluminescence analyzer (fujirebio lumipulse g1200): 22 mau/ml (reference range: 0-40 mau/ml).The patient's magnetic resonance imaging (mri) examination showed no abnormality.The customer believed that the wako result was correct.The customer suspected an interference.

• 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: 22148851
• Report Number: 1823260-2025-01725
• Device Sequence Number: 20795709
• 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): 08/01/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 07026706190
• Device Lot Number: 80176901
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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 Age: 51 YR
• Patient Sex: Female