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

Catalog Number	07682913001
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration recovery data provided was within specification.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hbsag ii results for multiple patient samples on a cobas e 801 module.The customer provided an example of discrepant results for 11 patient samples tested.The customer complained that they have had an increase in positive and borderline results that are negative upon repeat on another module.Sample 1 had an initial result of 1.05 coi.The repeat result was 0.704 coi.Sample 2 had an initial result of 1.03 coi.The repeat result was 0.463 coi.Sample 3 had an initial result of 1.28 coi.The repeat result was 0.496 coi.Sample 4 had an initial result of 1.1 coi.The repeat result was 0.438 coi.Sample 5 had an initial result of 1.26 coi.The repeat result was 0.461 coi.Sample 6 had an initial result of 1.43 coi.The repeat result was 0.626 coi.Sample 7 had an initial result of 1.61 coi.The repeat result was 0.621 coi.Sample 8 had an initial result of 1.47 coi.The repeat result was 0.379 coi.Sample 9 had an initial result of 1.13 coi.The repeat result was 0.594 coi.Sample 10 had an initial result of 1.06 coi.The repeat result was 0.44 coi.Sample 11 had an initial result of 1.06 coi.The repeat result was 0.651 coi.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.On 02-feb-2026, the customer replaced the reagent with a new lot.The customer retested 6 previous false positive samples and 5 tested negative.The sixth sample tested positive again but was repeated twice more and both results were negative.On (b)(6) 2026, the customer reported 9 initial positive samples that tested negative after duplicate testing.The field service engineer (fse) exchanged the sipper nozzle.The service maintenance actions performed by the fse 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 46250-0457
• MDR Report Key: 24379879
• Report Number: 1823260-2026-00576
• Device Sequence Number: 10567999
• 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): 04/01/2026

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
• Device Lot Number: 89826501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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