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	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with glucose hk gen.3 assay and 1 patient sample tested with phosphate (inorganic) ver.2 assay on a cobas c 703 analytical unit.Sample 1: glucose: initial result: 139 mg/dl.Repeat result: 678 mg/dl (tested on a c 503).Sample 2: phosphate: initial result: 0.356 mmol/l.Repeat result: 1.52 mmol/l (tested on a different c 703).The ward physician noticed that the initial results did not match the patients' clinical pictures, prompting the repeat of sample 1 and sample 2.The repeat results were consistent with the patients' clinical pictures.
Additional Manufacturer Narrative
The glucose hk gen.3 reagent lot number was 91927601 with an expiration date of 28-feb-2027.The phosphate (inorganic) ver.2 reagent lot number was 92792301 with an expiration date of 31-mar-2027.The calibrations for glucose and phosphate were performed on 11-apr-2026, and they both were acceptable.The qc for glucose was within the ranges, but at the upper limit.The qc for phosphate was outside the ranges.The field service engineer (fse) found that the sample needle cap was not properly sealed.He replaced the sample needle.Precision studies, calibration, and qc were performed, and they were within specifications.The service actions of replacing the sample probe resolved the issue.The cause of the event was consistent with a hardware issue (defective sample probe).

• 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: 25072626
• Report Number: 1823260-2026-01729
• Device Sequence Number: 16057074
• 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): 05/04/2026

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: 04/13/2026
• Initial Report FDA Received Date: 05/04/2026
• 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