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	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable sodium results from the cobas 6000 c 501 analyzer.The samples were repeated on a cobas pure c303 analyzer.Patient 1 initial result was 130 mmol/l and the repeat result was 141 mmol/l.On (b)(6) 2024, patient 2 initial result was 129 mmol/l and the repeat result was 135 mmol/l.On (b)(6) 2024, patient 3 initial result was 132 mmol/l and the repeat result was 139 mmol/l.The repeat results were believed correct.
Additional Manufacturer Narrative
The electrode lot number and expiration date were not provided.The field service engineer cleaned, recalibrated, and ran precision testing.The analyzer alarm trace contained abnormal sample aspiration alarms.The investigation did not identify a product problem.The specific cause of the event could not be determined.

• 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: 19117787
• Report Number: 1823260-2024-01173
• Device Sequence Number: 7099750
• Product Code: JJE
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 04/16/2024

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 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: 03/25/2024
• Initial Report FDA Received Date: 04/16/2024
• 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 Age: 35 YR
• Patient Sex: Female