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

Catalog Number	05860636001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The k electrode expiration date was not provided.The c501 (ul) v module serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ise results for 6 patients¿ samples tested on a cobas 6000 c501 (ul) v module.Results for the potassium (k) test were affected.Patient 1: initial result: 3.0 mmol/l.Repeat result: 4.5 mmol/l.Patient 2: initial result: 3.8 mmol/l.Repeat result: 4.8 mmol/l.Patient 3: initial result: 4.4 mmol/l.Repeat result: 4.9 mmol/l.Patient 4: initial result: 5.5 mmol/l.Repeat result: 4.5 mmol/l.Patient 5: initial result: 6.7 mmol/l.Repeat result: 4.5 mmol/l.Patient 6: initial result: 3.1 mmol/l.Repeat result: 3.91 mmol/l.The medical providers questioned the initial results, and the samples were repeated on a different cobas analyzer.The repeat results were deemed to be correct.Reportedly, amended reports with the correct results were issued on (b)(6) 2025.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, and g1 were updated.The visual check of the sample did not show any abnormality.The qc recovery was within the acceptable range.The alarm trace did not show any abnormality.The customer was able to resolve the issue by conditioning the ion-selective electrode (ise).No further issues were reported afterward.The investigation did not identify a product problem.The 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: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 22116555
• Report Number: 1823260-2025-01680
• Device Sequence Number: 7157455
• Product Code: JJE
• UDI-Device Identifier: 07613336227770
• UDI-Public: 07613336227770
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 06/05/2025

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): Follow-Up
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/05/2025
• 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: 77 YR
• Patient Sex: Female