MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 503 ANALYTICAL UNIT; CLINICAL CHEMISTRY ANALYZER

Catalog Number	08463662001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable lithium results for 1 patient sample on a cobas c 503 module.The initial result was 1.27 mmol/l.The repeated result was 0.326 mmol/l.The questionable result was reported outside the laboratory.The medical personnel complained about the high result which caused the customer to repeat the test.
Additional Manufacturer Narrative
The reagent lot number and expiration date were not provided.A precision check was performed with acceptable results.The field service representative cleaned the flowpath and replaced a probe.He measured the rinse volume by performing an air purge and performed checks with acceptable results.The investigation is ongoing.
Additional Manufacturer Narrative
No findings were reported for the provided water samples.The investigation confirmed that although foreign substances were attached to the surface of the inner wall of the provided reagent probes, the probes met specification tests.The origin of the foreign substances could not be found.The investigation did not identify a product problem.

• Brand Name: COBAS C 503 ANALYTICAL UNIT
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18649371
• Report Number: 1823260-2024-00331
• Device Sequence Number: 7111958
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K191899
• 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): 05/23/2025

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: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 05/23/2025
• 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