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

Catalog Number	03246353001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode lot number was p96 with an expiration date of 31-aug-2024.The chloride electrode lot number was k12 with an expiration date of 17-jul-2024.The field service engineer replaced valves, cleaned the ise, and ran activator.The customer ran qc that passed.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable ise indirect gen 2 results from the cobas 6000 c 501.The initial sodium result was 105 mmol/l with a data flag and the repeat result was 137 mmol/l.The initial chloride result was 131.1 mmol/l with a data flag and the repeat result was 98.4 mmol/l.The questionable results were not reported outside of the laboratory.The repeat results were believed 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: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18831713
• Report Number: 1823260-2024-00645
• Device Sequence Number: 7720996
• Product Code: JJE
• UDI-Device Identifier: 08430215043561
• UDI-Public: 08430215043561
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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: 07/17/2024
• Device Catalogue Number: 03246353001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 03/04/2024
• 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