MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number	07682913001
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys vitamin d total ii (vitamin d ii) on a cobas 8000 e 801 module.The initial result was 107 ng/ml.The repeat result was 46 ng/ml.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The vitamin d ii reagent lot number and expiration date were not provided.The customer noticed bubbles in the cleancell tubing; the tubing was replaced.The sipper nozzle and other tubing were also replaced.The issue was not resolved.On 21-jan-2026, the field service engineer (fse) replaced the cleancell tubing due to bubbles in the circuit.The gear pump head was replaced and adjusted.An instrument check was not acceptable.On 22-jan-2026, the fse replaced the sipper nozzle and the measuring cells.The instrument check was not acceptable.The fse returned to the customer site and still saw bubbles in the cleancell circuit; the tubing was replaced, but the bubbles remained.The fse replaced the syringe seals.The investigation is ongoing.

• Brand Name: COBAS 8000 E 801 MODULE
• 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: 24306011
• Report Number: 1823260-2026-00456
• Device Sequence Number: 13164015
• Product Code: JJE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/10/2026

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 Catalogue Number: 07682913001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 09/10/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Sex: Unknown