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

Catalog Number	05964067001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable calcium gen.2 and total protein gen.2 assay results for one patient's sample tested on the cobas 8000 cobas c 502 module.Calcium gen.2 the initial result was 7.7 mg/dl with a data flag.The repeat result was 9.7 mg/dl.Total protein gen.2 the initial result was 4.9 g/dl with a data flag.The repeat result was 7.2 g/dl.The initial results were deemed low and were questioned by the doctor, prompting the rerun.
Additional Manufacturer Narrative
The reagent lot numbers are: calcium gen.2 - 92646101 (expiration date: 28-feb-2027).Total protein gen.2 - 91836001 (expiration date: 31-jan-2027).The investigation reviewed the data set provided by the customer: the calibration results were within the specified ranges.The qc showed results outside the 2-standard deviation range.The alarm trace had "sample pipetter adjustment failure and sample probe up/down" alarms.The customer replaced and adjusted the sample probe.The field service engineer inspected the module and did not find the exact cause of the event.He rechecked and readjusted the sample probe, gear pump pressure, and water levels; tightened the screw securing the sample syringe plunger; corrected the screw; and inspected the syringe seals.He verified the module's performance with successful air purges, mechanical checks, precision checks, calibrations, and qs.The customer has not reported any other issues after the service.The customer has not reported any other issues after the service.

• 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: 25275077
• Report Number: 1823260-2026-02058
• Device Sequence Number: 13103730
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/26/2026

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: 05/01/2026
• Initial Report FDA Received Date: 05/26/2026
• 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: 62 YR
• Patient Sex: Male