MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 303 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	09793194001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with calcium gen.2 assay, 2 patients' samples tested with glucose hk gen.3 assay, 1 patient sample tested with alkaline phosphatase acc.To ifcc gen.2 assay, alanine aminotransferase acc.To ifcc ii assay, calcium gen.2 assay, total protein gen.2 assay, 1 patient sample tested with magnesium gen.2 assay, 1 patient sample tested with total protein assay, 1 patient sample tested with hdl-cholesterol gen.4 assay on a cobas c 303 analytical unit.Patient 1: calcium: initial result: 6.5 mg/dl.Repeat result: 10.0 mg/dl.Patient 2: glucose: initial result: 14.8 mg/dl.Repeat result: 96.3 mg/dl, and this result was deemed to be correct.Patient 3: alkaline phosphatase: initial result: 56.7 u/l.Repeat result: 127 u/l.Alanine aminotransferase: initial result: 16.7 u/l.Repeat result: 32.9 u/l.Calcium: initial result: 1.84 mg/dl (accompanied by a data flag).Repeat result: 9.07 mg/dl.Total protein: initial result: 3.14 g/dl.Repeat result: 5.84 g/dl.Patient 4: magnesium: initial result: 3.95 mg/dl (accompanied by a data flag).Repeat result: 2.15 mg/dl.Patient 5: total protein: initial result: 7.60 g/dl.Repeat result: 3.34 g/dl.Patient 6: hdl-cholesterol: initial result: 63.5 mg/dl.Repeat result: 39.5 mg/dl.Patient 7: glucose: initial result: 200 mg/dl.Repeat result: 59.9 mg/dl patient 8: calcium: initial result: 6.53 mg/dl.Repeat result: 9.98 mg/dl.Data flags accompanying other test results prompted the repeat of the samples."some" of the repeat results were deemed to be correct.
Additional Manufacturer Narrative
The calcium gen.2 reagent lot number was 920240.The glucose hk gen.3 reagent lot number was 919276.The alkaline phosphatase acc.To ifcc gen.2 reagent lot number was 935593.The alanine aminotransferase acc.To ifcc ii reagent lot number was 918221.The total protein gen.2 reagent lot number was 918054.The magnesium gen.2 reagent lot number was 899103.The hdl-cholesterol gen.4 reagent lot number was 894019.The calcium gen.2, glucose hk gen.3, alkaline phosphatase acc.To ifcc gen.2, alanine aminotransferase acc.To ifcc ii, total protein gen.2, magnesium gen.2, hdl-cholesterol gen.4 reagents' expiration dates were not provided.The qc was acceptable.The field service engineer (fse) detected an overflow/carry-over at the reaction cells, where the end of the tube at the vacuum vessel was cracked, causing a vacuum leak.He trimmed the end of the tube, which fixed the vacuum leak.He then checked the rinse levels, performed calibration and qc, and they were within specifications.The service actions of trimming the end of the tube resolved the issue locally.The cause of the event was due to a damaged rinse tube on the vacuum vessel.

• Brand Name: COBAS C 303 ANALYTICAL UNIT
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• 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: 25257321
• Report Number: 1823260-2026-02030
• Device Sequence Number: 10541960
• Product Code: JJE
• UDI-Device Identifier: 07613336220153
• UDI-Public: 07613336220153
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K220134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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 Catalogue Number: 09793194001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• 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