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	Contamination (1120); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca2 reagent lot number was 920240 with an expiration date of 31-jan-2027.On 08-apr-2026, the field service engineer (fse) found an issue at the cell rinse station related to the cleaning adjustment.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for calcium gen.2 (ca2) on a cobas c 703 analytical unit.The initial result was 5.04 mg/dl.The repeat result was 8.87 mg/dl.The sample was repeated again with a result of 8.80 mg/dl.

• 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: 24987407
• Report Number: 1823260-2026-01598
• Device Sequence Number: 18761959
• Product Code: JJE
• UDI-Device Identifier: 07613336200544
• UDI-Public: 07613336200544
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup
• Report Date (Section B): 05/14/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/14/2026
• 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