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	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number is 788473.The expiration date was not provided.The calibration data was acceptable.The alarm trace did not indicate any issues.The field service engineer (fse) found an issue with the gear pump head.He replaced the gear pump head and adjusted the rinse and pressure to specifications.He cleaned the sample and reagent probe pathways.The customer ran qc which passed.The fse ran a photometer check, hardware performance check, and precision with acceptable results.The investigation determined the service actions resolved the issue.
Event or Problem Description
There was an allegation of questionable cobas integra glucose hk gen.3 results from the cobas 6000 c 501 module.Sample 1 initial result was 24 mg/dl and the repeat results from another analyzer were 91.6 mg/dl and 91.9.The repeat result from the original analyzer was 91.0 mg/dl.Sample 2 initial result was 12.0 mg/dl and the repeat result was 76.3 mg/dl.Sample 3 initial result was 20 mg/dl and the repeat result was 103 mg/dl.Sample 4 initial result was 12 mg/dl and the repeat result was 77 mg/dl.The questionable result for sample 1 was not reported outside of the laboratory.The repeat results were believed to be 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
• MDR Report Key: 20561606
• Report Number: 1823260-2024-03125
• Device Sequence Number: 16922640
• Product Code: JJE
• UDI-Device Identifier: 04015630946402
• UDI-Public: 04015630946402
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 10/29/2024

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: 10/16/2024
• Initial Report FDA Received Date: 10/29/2024
• 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