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

Catalog Number	05860636001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable tina-quant hba1c gen.3 results from three patient samples tested on the cobas 6000 c 501 (ul) v.Patient sample 1.On (b)(6) 2025: the initial result of the initial patient sample was 12.1%.The repeat result matched the initial result.On (b)(6) 2025: the result of a new patient sample was 4.7%.Patient sample 2.On (b)(6) 2025: the initial result of the initial patient sample was 8.9%.The repeat result matched the initial result.On (b)(6) 2025: the result of a new patient sample was 4.9%.Patient sample 3.On (b)(6) 2025: the initial result of the initial patient sample was 8.9% on (b)(6) 2025: the result of a new patient sample from another analyzer was 4.8%.The doctor questioned the initial results and requested a new patient sample collection, as the initial results did not match the patient's clinical picture.The results of the new patient samples were deemed correct.
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c501 (ul) v is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The analyzer serial number was updated.The calibration and qcs were within the specified ranges.The field service engineer inspected the module and determined that the sample probe had caused the event.He performed instrument checks, rinse water, and cell blank water tests.He checked the gear pump pressure and cleaned the sample probe.He performed precision checks with successful results.The customer did not report any other issues after the service.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: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21925236
• Report Number: 1823260-2025-01323
• Device Sequence Number: 4059620
• Product Code: JJE
• UDI-Device Identifier: 04015630926275
• UDI-Public: 04015630926275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/15/2025

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: 04/30/2026
• Device Catalogue Number: 05860636001
• Device Lot Number: 81997601
• 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: 04/03/2025
• Supplement Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/15/2025
• 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