MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C501 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	04745914001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calcium gen.2 reagent lot number is 931854.The expiration date was not provided.Reagent issues were excluded as no further cases were reported, and correct reruns were performed with the same reagent.During the field service engineer's follow-up service visit, he inspected the module and found water droplets below the cell rinse unit.He then cleaned the vacuum path and the sample probe, and confirmed that the assay and module were again performing according to specifications.The investigation determined that a component malfunction had caused the event.The investigation determined that the service actions resolved the issue.
Event or Problem Description
The initial reporter received questionable calcium gen.2 assay results for multiple patient samples tested on the cobas 6000 c501 module.The reporter stated that the assay's initial and repeat patient results differed by 3 units.The field service engineer inspected the module and found a droplet leaking from the cell rinse unit.He cleaned the nozzle and teflon tip, repaired the vacuum circuit, and performed a successful mechanical check.The event was not resolved, and the reporter noted consistently lower assay patient results.No questionable result was reported outside the laboratory.

• Brand Name: COBAS 6000 C501 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
• MDR Report Key: 25532559
• Report Number: 1823260-2026-02402
• Device Sequence Number: 9313079
• Product Code: JJE
• UDI-Device Identifier: 04015630924707
• UDI-Public: 04015630924707
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 06/17/2026
• 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