MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 703 ANALYTICAL UNIT; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	C703
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter establishment name: (b)(6).The reagent lot number is 89633001 with an expiration date of 28-feb-2027.The field service representative found an issue with the wash station.The wash station was repaired, which resolved the issue.He performed checks and tests with acceptable results.The investigation determined that the service actions resolved the issue.However, a specific cause of the event could not be determined.
Event or Problem Description
There was an allegation of questionable bilt3 bilirubin total gen.3 results for 1 patient sample on a cobas c 703 analytical unit.The initial result was 0.15 mg/dl.On (b)(6) 2026, the sample was repeated on another module, and the result was 5.03 mg/dl.This result matched the patient's clinical picture.The sample was repeated because the initial result did not match the patient's clinical picture.

• Brand Name: COBAS C 703 ANALYTICAL UNIT
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• 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: 25152712
• Report Number: 1823260-2026-01870
• Device Sequence Number: 21170111
• Product Code: JJE
• UDI-Device Identifier: 07613336200544
• UDI-Public: 07613336200544
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K253490
• 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
• Report Date (Section B): 05/12/2026

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 Model Number: C703
• Device Catalogue Number: 09502971001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/12/2026
• 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
• Patient Ethnicity: Non Hispanic