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

Model Number	C703
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable total protein gen.2 assay results for two patient samples tested on the cobas c 703 analytical unit.On (b)(6) 2026: patient sample 1 the initial result was 31.2 g/l.The repeat result was 64.8 g/l.The initial result was deemed low, prompting the rerun.The repeat result aligns with the patient's previous results.The field service engineer inspected the analyzer, verified the cuvette rinsing, adjusted the ultrasonic mixer (usm), replaced the sample probe, and performed a precision check.The issue was not resolved, and new questionable results were reported.On (b)(6) 2026: patient sample 2 the initial result was 23 g/l.The repeat result was 60 g/l.
Additional Manufacturer Narrative
The reagent lot number is 932865.The expiration date was requested but not provided.The field service engineer inspected the analyzer; replaced the photometric lamp, cuvettes, reagent probe, and solenoid valve; and readjusted the ultrasonic mixer.The investigation determined that the event was consistent with a hardware issue.The specific cause of the event could not be determined.The investigation determined that the service actions resolved the issue.

• 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: 25297110
• Report Number: 1823260-2026-02069
• Device Sequence Number: 9315406
• 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): 05/27/2026

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: 05/04/2026
• Initial Report FDA Received Date: 05/27/2026
• 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