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

Catalog Number	05860636001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.The investigation determined that a hardware issue had caused the event.The customer has not reported any other issues after the service.The investigation determined that the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable tina-quant hemoglobin a1c gen.3 - hemolysate and whole blood application results from one patient sample tested on the cobas 6000 c (501) module.The following examples of discrepant results were provided: on 26-apr-20206: the initial result from the module was 10.9%.On 29-apr-20206: the field service engineer inspected the module and found the basic wash was overflowing into cells due to damaged vacuum tubing.He replaced this part, as well as the rinse water tubing, and adjusted rinse levels to specification.He also cleaned the precipitated basic wash from the top of the cells, the electrodes, and the electrode block fittings.He verified the module's performance with mechanism checks, cell blank measurement, ion-selective electrode checks, qcs, and customer-run patient comparison tests.The repeat result from the module after service was 5.3%.The repeat result from another module was 4.8%.The doctor questioned the initial result, prompting the rerun.The repeat results were deemed correct.

• 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
• MDR Report Key: 25239875
• Report Number: 1823260-2026-02005
• Device Sequence Number: 10623196
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 05/21/2026

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/21/2026
• 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