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

Catalog Number	05860636001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c501 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable high results for an unspecified number of patient samples tested with the na electrode on a cobas 6000 c (501) module.The customer tried re-calibrating and ran controls.The calibration failed.The customer then replaced the electrodes and reagent.Calibration performed on the standby reagents was successful, but the calibration with the in-use reagent failed.Controls failed on both standby and in-use reagents.The customer provided data for one patient sample that had discrepant na results.No questionable results were reported outside of the laboratory.The sample initially resulted in a na value of 171 mmol/l.The customer decided to repeat the sample since the initial value was high.The sample was repeated, resulting in a value of 137 mmol/l.The repeat value was deemed correct.
Additional Manufacturer Narrative
The field service engineer determined the rinse tubing was broken.The tubing was replaced.Precision studies were performed and recovered within specifications.The investigation determined the service actions resolved the issue.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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: 20561642
• Report Number: 1823260-2024-03124
• Device Sequence Number: 8821390
• Product Code: JJE
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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): 11/26/2024

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
• 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: 10/09/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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