MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS C 502 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964067001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vancomycin reagent lot number was 82317101.The expiration date was not provided.The provided calibration showed no abnormalities.The provided qc was within the ranges on the day of the event.The provided alarm trace showed multiple sample short alarms.These are indicators of possible poor sample quality.The field service engineer (fse) found that the instrument needed to be decontaminated.He decontaminated the instrument and replaced the valves, the mixers, the vacuum module, the pump head, and the sample probe.Precision studies and some checks were performed, and they were within specifications.The fse verified that the instrument was performing within specifications.The service actions performed by the fse resolved the issue.No further issues were reported after the service visit.The root cause was due to a hardware issue.
Event or Problem Description
We received an allegation about discrepant results for 2 patients' samples tested with online tdm vancomycin gen.3 assay on a cobas 8000 cobas c 502 module.Patient 1: initial result: 70.7 ug/ml (accompanied by ">critical range" data flag).Repeat result: 15.9 ug/ml.Patient 2: initial result: 42.9 ug/ml (accompanied by ">critical range" data flag).Repeat result: 8.9 ug/ml.The clinician/pharmacy questioned the initial results, prompting the original samples for patient 1 and patient 2 to be repeated on a different analyzer and the test to be reordered.The repeat values were deemed correct.

• Brand Name: COBAS 8000 COBAS C 502 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: 24575712
• Report Number: 1823260-2026-00862
• Device Sequence Number: 13359957
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• 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): 03/11/2026

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: 05964067001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/11/2026
• 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 Age: 81 YR
• Patient Sex: Male