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

Catalog Number	07682913001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hbsag ii results from the cobas 8000 e 801 module for approximately 17 patients.Here are 4 representative examples.Patient 1's initial result was 1.12 coi (reactive).The first repeat result was 0.495 coi (non-reactive).The second repeat result was 0.463 coi (non-reactive).Patient 2's initial result was 3.55 coi (reactive).The first repeat result was 0.314 coi (non-reactive).The second repeat result was 0.368 coi (non-reactive).Patient 3's initial result was 3.47 coi (reactive).The first repeat result was 0.512 coi (non-reactive).The second repeat result was 0.480 coi (non-reactive).Patient 4's initial result was 0.44 coi (non-reactive).The first repeat result was 7.97 coi (reactive).The sample was sent to another laboratory, and the result was non-reactive.The exact result was not provided.
Additional Manufacturer Narrative
The elecsys hbsag ii reagent lot number is 863553, and the expiration date is 31-dec-2026.A field service engineer (fse) determined that there were bubbles in the sippers and syringes.The fse replaced the degasser and the gear pump head and adjusted the water pressure.Qc was completed and passed.The investigation determined that the service action resolved the issue.

• 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: 24886104
• Report Number: 1823260-2026-01432
• Device Sequence Number: 9823598
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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
• Report Date (Section B): 04/15/2026

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/15/2026
• 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 Sex: Unknown