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

Catalog Number	05860636001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable ise indirect na-k-cl for gen.2 results for 1 patient sample on a cobas 6000 c (501) module.This medwatch will cover potassium.Refer to medwatch with a1 patient identifier (b)(6) for information on the chloride results and medwatch with a1 patient identifier (b)(6) for information on the sodium results.The initial na result was 104 mmol/l, the initial k result was 3.5 mmol/l, and the initial cl result was 73.2 mmol/l.The customer questioned the results which prompted them to repeat the sample.The sample was repeated on another c 501 analyzer and the na result was 129 mmol/l, the k result was 4.32 mmol/l, and the cl result was 94.3 mmol/l.The repeat results were deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
It was found that the customer's centrifugation time may be shorter than recommended, and the spin speed may be faster than recommended.The alarm trace did not contain a conspicuous event.The field service engineer (fse) found that the vacuum on the rinse nozzle was not working and found a crack in the ise acrylic block.The fse rerouted the vacuum tubing, replaced the acrylic block, ise electrodes, valve bank, and rinse water check valve, cleaned the sample probe, sipper nozzle, internal standard and reference dispense nozzles, and the detergent probe, decontaminated the sipper flow path, verified gear and water pump pressure, adjusted rinse levels, and performed ise checks, precision testing, calibration, and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 23830045
• Report Number: 1823260-2025-05172
• Device Sequence Number: 14725772
• Product Code: JJE
• UDI-Device Identifier: 07613336227770
• UDI-Public: 07613336227770
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/05/2026

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: 05860636001
• Device Lot Number: ASKU
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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