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

Catalog Number	05860636001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c (501) module serial number is (b)(6).The customer stated that qc was passing prior to the event.The customer also stated that qc was run again once the issue was discovered and failed.Calibration was rerun and had a flag upon completion.Qc was repeated that evening and was in range and better with some points still high.Some results were high and out of range.Qc passed again on 25-sep-2025.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable triglycerides results from the cobas 6000 c (501) module for approximately 30 to 40 patients.The customer alleges that the triglyceride results started running high, 200 mg/dl - 600 mg/dl.The doctors recognized the high results and questioned them.Exact results and repeat results have not been provided.
Additional Manufacturer Narrative
The medwatch section d, device identification was updated.Relevant fields of sections d and g were updated.Patient results were provided.The initial result was 452 mg/dl, and the repeat result was 131 mg/dl.A field service engineer (fse) determined that there was a hole in the vacuum side of the rinse tubing due to wear and tear.The fse replaced the rinse mechanism tubing and completed mechanism checks, and observed that the rinse levels and pressure were within specifications.A 21-cup precision check was completed as well and an ion-selective electrode (ise) check, all of which passed specifications.The investigation determined that the service action 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: 23308250
• Report Number: 1823260-2025-04214
• Device Sequence Number: 17589698
• Product Code: JJE
• UDI-Device Identifier: 04015630918393
• UDI-Public: 04015630918393
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/31/2025

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 Catalogue Number: 05860636001
• Device Lot Number: 86149901
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 10/31/2025
• 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