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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable glucose hk gen.3 assay results for two patient samples tested on the cobas c 703 analytical unit.Patient sample 1: on (b)(6)2026: the initial result was (b)(6).The repeat result was (b)(6).Patient sample 2: on (b)(6)2026: the initial result from the analyzer was (b)(6).The initial result was deemed clinically incorrect.The repeat result from another c 703 analyzer using a different lot was (b)(6).The repeat result was deemed correct.
Additional Manufacturer Narrative
The glucose hk gen.3 reagent lot number is 951751.The expiration date was not provided.

• 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 -045
• 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: 50667217
• Report Number: 1823260-2026-03649
• Device Sequence Number: 9540062
• Product Code: JJE
• UDI-Device Identifier: 07613336200544
• UDI-Public: 07613336200544
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K253490
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/08/2026

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
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/08/2026
• 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