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	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c 501 serial number was (b)(6).The customer performed air purges, cleaned the ise probe, primed the ise reagents, and performed ise checks.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable low ise indirect gen 2 results from the cobas 6000 c 501 analyzer.The samples were repeated on a cobas pure analyzer and then on the cobas 6000 analyzer.Sample 1 initial result was 130 mmol/l and the repeat results were 138 mmol/l on a cobas pure analyzer and 139 mmol/l on a cobas 6000 analyzer.Sample 2 initial result was 131 mmol/l and the repeat result was 139 mmol/l on a cobas pure analyzer.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer did not determine a specific cause but found the sample probe was slightly misadjusted.He performed proactive steps, by flushing the rinse tubing, the vacuum valves, and the ise valves.He adjusted the sample probe and the ise sipper.He ran successful calibration and qc and a patient comparison.The investigation determined the issue was resolved by the service actions.

• 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: 18847632
• Report Number: 1823260-2024-00673
• Device Sequence Number: 12720772
• Product Code: JJE
• UDI-Device Identifier: 04015630946402
• UDI-Public: 04015630946402
• 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,Followup
• Report Date (Section B): 04/03/2024
• 2 Devices were Involved in the Event: 1 2

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: 02/13/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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