MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (DISK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E 411
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The elecsys hcg stat reagent lot number is 869013, with an expiration date of 31-oct-2026.The field applications specialist (fas) inspected the analyzer reagents, the onboard reagents, the diluents, bead mixer, wash and rinse stations, sample disks, sipper probe, sample and reagent probes' drying cylinder, syringes, probes, system water, calibrations, and qcs.The fas inspected patient sample 3, and no issues were found.This patient sample was rerun, and the result was 38905 miu/ml, which correlated with the reported result.The fas noted that the customer uses a 1:20 dilution factor.Product labeling states, "dilution - samples with hcg concentrations above the measuring range can be diluted with diluent universal 2.The recommended dilution is 1:100 (either automatically by the analyzers or manually).The concentration of the diluted sample must be > 100 miu/ml.The field service engineer (fse) performed mechanical and instrument checks.He verified the alignments of the sample and reagent probes, the sipper, and the bead mixer.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg stat assay results for three patient samples tested on the cobas e 411 analyzer (disk system).Patient sample 1 on (b)(6) 2026: the initial result was 193365 miu/ml with a data flag.On (b)(6) 2026: the initial result was 151608 miu/ml with a data flag.The patient underwent a scan for threatened abortion and result correlation.The patient's scan showed a fetus with a healthy heartbeat.Patient sample 2 on (b)(6) 2026: the initial result was 444.9 miu/ml with a data flag.The patient questioned the result as it did not match her clinical picture, and the hcg beta result from a competitor analyzer was 114000 miu/ml.On (b)(6) 2026: the repeat result with the patient sample at 1:100 dilution was 121754 miu/ml with a data flag.On the field service engineer's (fse) initial service visit, he inspected the analyzer and performed mechanical and instrument checks.He verified the conditions and alignment of the parts, including the probes and the mixer.On his follow-up service visit, he reviewed the qc graphs, proficiency results, and the analyzer logs.Patient sample 3 on (b)(6) 2026: the initial result was >10000 miu/ml with a data flag.The first repeat result with the patient sample at 1:20 dilution was 37663 miu/ml with a data flag.The second repeat result with the patient sample at 1:20 dilution was 39491 miu/ml with a data flag.

• Brand Name: COBAS E 411 ANALYZER (DISK SYSTEM)
• Common Device Name: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 24886110
• Report Number: 1823260-2026-01430
• Device Sequence Number: 9824083
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K961481
• 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): 05/22/2026

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 Model Number: E 411
• Device Catalogue Number: 04775279001
• 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: 03/24/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 05/22/2026
• 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: 28 YR
• Patient Sex: Female