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

Catalog Number	07682913001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was requested but was not provided.The field service engineer (fse) found defective pinch valves.After replacement, an instrument check was performed and passed.Following the fse intervention, no further incidents were reported.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys anti-hbc assay results for patient samples tested on a cobas 8000 e 801 module.Sample 1 the initial result was 0.000948 coi (reactive).The repeat results were 0.000899 coi (reactive), 0.000893 coi (reactive), and 2.21 (non-reactive).Sample 2: the initial result was 0.000937 coi (reactive).The repeat results were 0.0307 coi (reactive), 0.00107 coi (reactive), and 2.18 (non-reactive).Sample 3: the initial result was 0.000980 coi (reactive).The repeat results were 0.188 coi (reactive), 2.14 coi (non-reactive), and 2.14 (non-reactive).Sample 4: the initial result was 0.00183 coi (reactive).The repeat results were 0.000923 coi (reactive), 1.54 coi (non-reactive), and 1.54 (non-reactive).Sample 5: the initial result was 0.00102 coi (reactive).The repeat results were 0.00185 coi (reactive), 2.13 coi (non-reactive), and 2.25 (non-reactive).

• 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: 24969775
• Report Number: 1823260-2026-01568
• Device Sequence Number: 10580880
• Product Code: JJE
• UDI-Device Identifier: 04015630946198
• UDI-Public: 04015630946198
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060373
• 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): 05/29/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/29/2026
• 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