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

Catalog Number	05860636001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 c 501 (ul) (b)(6).The field service engineer (fse) inspected the module and determined that a misaligned sipper spring inside the sipper compartment had caused the event.He cleaned the electrode block, primed the electrodes, checked for leaks, cleaned the ion-selective electrode bath, and verified the rinse levels and the sipper nozzle spring's position.He verified the module's performance with successful calibrations.Qcs, precision checks, and patient comparison tests.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable na electrode results from a few patient samples tested on the cobas 6000 c 501 (ul) v.One example of discrepant results was provided: the initial na result from the module was 132 mmol/l.The repeat result from a cobas 8000 analyzer was 139 mmol/l.The doctor questioned the low results, prompting the rerun of the patient samples.The repeat result was deemed correct.
Additional Manufacturer Narrative
Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the customer's preanalytical handling data and noted that the patient sample was centrifuged for 5 minutes at 3500 rpm; according to the tube manufacturer¿s guidelines, the centrifugation time may be too short, and the speed may be too high.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: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21975787
• Report Number: 1823260-2025-01405
• Device Sequence Number: 13058577
• Product Code: JJE
• UDI-Device Identifier: 07613336227763
• UDI-Public: 07613336227763
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/10/2025

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 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): Initial
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/10/2025
• 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