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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested for cholesterol on a cobas c 703 analytical unit.The second sample also had discrepant results for glucose hk gen.3.The customer repeated the samples as the initial values did not agree with the previous results of the patients.The repeat results were deemed correct.The first sample initially resulted in a cholesterol value of 1.30 mmol/l and it repeated as 5.31 mmol/l.The second sample initially resulted in a cholesterol value of 1.94 mmol/l and a glucose value of 1.40 mmol/l.The sample was repeated, resulting in a cholesterol value of 5.10 mmol/l and a glucose value of 4.34 mmol/l.
Additional Manufacturer Narrative
The cholesterol reagent lot number was 934751.The reagent expiration date was requested, but not provided.The glucose reagent lot number and expiration date were requested, but not provided.The field service engineer replaced a sample probe.All probes were adjusted.The lamp and cells were replaced and the lamp was re-calibrated.An instrument check was completed.The investigation determined 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: 25152711
• Report Number: 1823260-2026-01872
• Device Sequence Number: 15790660
• Product Code: JJE
• UDI-Device Identifier: 07613336200544
• UDI-Public: 07613336200544
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: 04/23/2026
• 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