MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE TDM THEOPHYLLINE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	08253153190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The online tdm theophylline reagent lot number and expiration date were not provided.Calibration and qc data during the event were within specifications.A field service engineer (fse) removed both sample probes and cleaned them.The fse refitted and adjusted the sample probes accordingly, and completed qc which was passing within specifications.The investigation is ongoing.
Event or Problem Description
There was an allegation of a questionable online tdm theophylline result from the cobas c 503 analytical unit for one patient.The initial result was no result generated, accompanied by a data flag.The first repeat result was 0.8 g/ml, accompanied by a data flag.The second repeat result was 12.7 g/ml.The third repeat result was 12.9 g/ml.
Additional Manufacturer Narrative
The medwatch section d, device identification was updated.Relevant fields of sections d and g were updated.The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.The issue was resolved after the sample probe was cleaned and adjusted.

• Brand Name: ONLINE TDM THEOPHYLLINE
• 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: 23826772
• Report Number: 1823260-2025-05145
• Device Sequence Number: 5080725
• Product Code: KLS
• UDI-Device Identifier: 07613336147931
• UDI-Public: 07613336147931
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K951595
• 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,Followup
• Report Date (Section B): 01/23/2026

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: 08253153190
• Device Lot Number: ASKU
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/23/2026
• 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