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

Catalog Number	05964067001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca2 reagent lot number was 92646101 with an expiration date of 28-feb-2027.The gluc3 reagent lot number was 92618001 with an expiration date of 28-feb-2027.Reagent issues were excluded as the customer had no further issues, and the correct repeat result was received using the same reagent.The field service engineer (fse) found leaky vacuum tubes and replaced them.The module was operating within specification.The investigation determined that the issue found by the fse was the root cause of the event.
Event or Problem Description
The initial reporter questioned the results for multiple patient samples and multiple assays on a cobas 8000 cobas c 502 module.Discrepant results were provided for 3 patient samples tested for glucose hk gen.3 (gluc3) and calcium gen.2 (ca2).Sample 1 initial ca2 result was 5.3 mg/dl with a data flag.The repeat result was 9.3 mg/dl."sample 4" initial gluc3 result was 17 mg/dl.The repeat result was 111 mg/dl."sample 5" initial gluc3 result was 40 mg/dl.The repeat result was 91 mg/dl.

• 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: 25531346
• Report Number: 1823260-2026-02387
• Device Sequence Number: 9175140
• Product Code: JJE
• UDI-Device Identifier: 04015630928354
• UDI-Public: 04015630928354
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: 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: 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: 05/27/2026
• 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