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	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sodium electrode lot number was aae93.The potassium electrode lot number was aeh95.The chloride electrode lot number was u8414.The field service engineer found the ise flow path was broken.He checked and cleaned the ise flowpath, reseated the sipper spring, primed the reagents, performed air purges, and ran ise checks.He ran precision testing that was acceptable.The investigation determined the service actions resolved the issue.Qc recovery was within the customer's established ranges, therefore, there was no indication of a performance issue with the reagent.
Event or Problem Description
There was an allegation of questionable ise results from the cobas 6000 c 501 analyzer.The initial sodium result was 116 mmol/l, the initial potassium result was 3.41 mmol/l, and the initial chloride result was 83.4 mmol/l.The initial results were reported outside of the laboratory and the patient was redrawn in the er.The results for the new sample were sodium 140 mmol/l, potassium 4.1 mmol/l, and chloride 105 mmol/l.The original sample was repeated on the same and another c501 analyzer.The sodium results were 140 mmol/l and 139 mmol/l, the repeat potassium results were 4.07 mmol/l and 4.12 mmol/l, and the repeat chloride results were 104.6 mmol/l and 104.0 mmol/l.

• 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
• MDR Report Key: 20360154
• Report Number: 1823260-2024-02859
• Device Sequence Number: 7208497
• Product Code: JJE
• UDI-Device Identifier: 04015630946402
• UDI-Public: 04015630946402
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 10/03/2024

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: 09/16/2024
• Initial Report FDA Received Date: 10/03/2024
• 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