MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 402 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793194001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) checked the ise electrode seating for moisture, checked the sipper, vacuum, and diluent and internal standard nozzles, verified sample probe adjustment, and adjusted detergent volumes.Ise checks, calibration, and precision testing was performed successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ise indirect na-k-cl for gen.2 (cl) results for 1 patient sample on a cobas c 303 analytical unit.The initial cl result was 79.2 mmol/l.The customer's laboratory information system flagged the result with a delta check which prompted the customer to repeat the sample.The repeat result was 99.8 mmol/l.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.The calibration and qc recovery data provided were within specifications.The alarm trace did not contain a conspicuous event.No further issues were reported after the service visit.The investigation determined that the service actions resolved the issue and verified the analyzer's performance.The root cause of the event could not be determined.

• Brand Name: COBAS E 402 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY 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: 24584413
• Report Number: 1823260-2026-00890
• Device Sequence Number: 9121175
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• 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): 04/10/2026

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 Expiration Date: 08/03/2026
• Device Catalogue Number: 09793194001
• Device Lot Number: FHA58
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/10/2026
• 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
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male