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	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c 501 (ul) v module serial number was (b)(6).The qc was within ranges on the day of the event.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with tina-quant c-reactive protein iv (crp4) assay on a cobas 6000 c 501 (ul) v module.Initial result: 3.00 mg/l (accompanied by a data flag).Data flags accompanying other test results, prompted the repeat of the sample.No questionable results were reported outside the laboratory.Repeat result: 405.5 mg/l.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
There was no indication of a performance issue with the reagent since the qc recovery was within ranges.The alarm trace did not show any abnormalities.The field service engineer changed the sample probe as a precautionary measure.Precision studies, calibration, and qc were performed, and they were all within specifications.No further issues were reported after the service visit.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: 22370157
• Report Number: 1823260-2025-01996
• Device Sequence Number: 7918649
• Product Code: JJE
• UDI-Device Identifier: 04015630946839
• UDI-Public: 04015630946839
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/21/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 05860636001
• Device Lot Number: 83969001
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 07/21/2025
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 84 KG