MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745914001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The creatinine reagent lot number was 93463301, with an expiration date of 31-oct-2026.The field service engineer found a hole in rinse tubing, causing cuvettes the overflow.The tubing was replaced.No further issues were reported after this action.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with creatinine plus ver.2 on a cobas 6000 c501 module.The customer initially had issues with linearity alarms for two other assays run on the analyzer.The customer replaced the lamp and performed a cell blank.The cell blank was successful.Linearity alarms returned, however, and on level of creatinine control shifted lower.Based on the control shift, the customer repeated patient sample testing for 240 samples.Of these, three had discrepant creatinine results.The first sample initially resulted in a creatinine value of 55 umol/l.The sample was repeated twice on a second analyzer on (b)(6) 2026, resulting in values of 91 umol/l and 87 umol/l.The second sample initially resulted in a creatinine value of 45 umol/l.The sample was repeated twice on a second analyzer on (b)(6) 2026, resulting in values of 119 umol/l and 118 umol/l.The third sample initially resulted in a creatinine value of 41 umol/l on (b)(6) 2026.The sample was repeated twice on a second analyzer on (b)(6) 2026, resulting in values of 133 umol/l and 134 umol/l.
Additional Manufacturer Narrative
Calibration data is acceptable.Quality control data showed instability.A review of alarm trace data showed several sample short alarms both before and after the day of the event.The sample centrifugation conditions of the sample may have not been suitable according to tube manufacturer recommendations.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C501 MODULE
• 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: 25347326
• Report Number: 1823260-2026-02147
• Device Sequence Number: 21364391
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K060373
• 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): 06/22/2026

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: 04745914001
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/01/2026
• Supplement Report FDA Received Date: 06/22/2026
• 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