MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number	CA GEN.2
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable low calcium gen.2 results from the cobas 6000 c 501 module.The samples were repeated on another cobas c501 at another site.Two examples were provided.Patient 1 initial result was 6.0 mg/dl.The repeat result was 8.5 mg/dl.Patient 2 initial result was 7.9 mg/dl.The repeat result was 8.4 mg/dl.The repeat results were believed to be correct.
Additional Manufacturer Narrative
The cobas 6000 c 501 serial number was (b)(6).The field service engineer found there was a bent sample probe.He adjusted the sample probe and ran precision testing, which passed.The customer ran qc, which passed.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.
Additional Manufacturer Narrative
The calibration and qcs were acceptable.The alarm trace did not indicate any issues.The investigation determined that the service actions resolved the issue.

• Brand Name: COBAS 6000 C (501) 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 46250-0457
• MDR Report Key: 22817672
• Report Number: 1823260-2025-02521
• Device Sequence Number: 5751744
• Product Code: JJE
• UDI-Device Identifier: 04015630924035
• UDI-Public: 04015630924035
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2025

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 Expiration Date: 03/31/2026
• Device Model Number: CA GEN.2
• Device Catalogue Number: 05860636001
• Device Lot Number: 85056701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 08/15/2025; 09/11/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/05/2025; 09/29/2025
• 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