MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 602 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number	05990378001
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The elecsys hsv-2 igg reagent lot number was 85719600.The expiration date was not provided.The field service engineer performed checks and could not establish a cause.He performed a check of the hardware components, verified the pump pressures and rinse volumes, and checked and verified proper pipettor/nozzle adjustments.He ran performance testing with results within specifications.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hsv-2 igg results from the cobas 8000 - cobas e 602 module.The initial result was 1.70 coi (reactive).The customer had a policy to repeat reactive results, so the sample was repeated in duplicate.The repeat results were non-reactive and were believed to be correct.A new sample was drawn from the patient and tested at a different laboratory, and the result was non-reactive/negative.
Additional Manufacturer Narrative
Based on the provided information, the investigation was unable to determine a specific root cause.A general reagent or analyzer problem was not present because the qc before the event was within ranges.

• Brand Name: COBAS E 602 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: 24188035
• Report Number: 1823260-2026-00289
• Device Sequence Number: 9851268
• Product Code: JJE
• UDI-Device Identifier: 04015630929764
• UDI-Public: 04015630929764
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: 05990378001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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: 65 YR
• Patient Sex: Male