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

Catalog Number	09015124190
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 4 patients' samples tested with elecsys alpha-fetoprotein (afp) assay on a cobas pure e402 analytical unit.Sample 1: initial result: 11.9 iu/ml.1st repeat result: 3.04 iu/ml.Sample 2: initial result: 10.3 iu/ml.1st repeat result: 1.18 iu/ml.Sample 3: initial result: 20.2 iu/ml.1st repeat result: 182.7 iu/ml.The physician questioned the initial results for sample 1, sample 2, and sample 3 as they were high, and the samples were then repeated for the 1st time on an e411).On (b)(6) 2025, sample 1, sample 2, and sample 3 were repeated after replacing a new reagent pack and performing calibration on the e402.Sample 1: 2nd repeat result: 3.4 iu/ml (tested on e402).3rd repeat result: 3.94 iu/ml (tested on e411).Sample 2: 2nd repeat result: 1.57 iu/ml (tested on e402).3rd repeat result: 1.38 iu/ml (tested on e411).Sample 3: 2nd repeat result: 165 iu/ml (tested on e402).3rd repeat result: 184.9 iu/ml (tested on e411).Also, on (b)(6) 2025, sample 4 was initially tested on e402, resulting in an afp value of 225 iu/ml.The sample was repeated on an e411 using another reagent lot number, and the repeat result was 1.19 iu/ml.
Additional Manufacturer Narrative
The afp reagent expiration date was not provided.Sample 4 was repeated using the afp reagent lot number 821474.The cobas pure e402 analytical unit serial number was (b)(6).The qc was within the ranges.The calibration was performed on 20-may-2025, and it failed with a dup.E alarm.The investigation is ongoing.
Additional Manufacturer Narrative
During troubleshooting, the field service engineer replaced the sample probe, reagent probe, measuring cell, and microbead mixer and performed the adjustments.The troubleshooting actions performed by the engineer resolved the issue.A general reagent problem can be excluded.The investigation did not identify a product problem.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: 22201806
• Report Number: 1823260-2025-01820
• Device Sequence Number: 12693590
• Product Code: LOJ
• UDI-Device Identifier: 07613336172025
• UDI-Public: 07613336172025
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 07/23/2025

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: 781901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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