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

Catalog Number	08463662001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The glucose reagent lot number and expiration date were not provided.The field service engineer (fse) readjusted the cell rinse levels and cleaned the cell rinse unit and the vacuum valves.The fse replaced one of the vacuum valves.The analyzer was operating within specification.Reagent issues were excluded as the customer had no further issues and the correct repeat result was received using the same reagent.The investigation determined the issue with the vacuum valve was the cause of the event.The service actions resolved the issue.
Event or Problem Description
The initial reporter questioned the results for 10 patient samples tested for multiple parameters on a cobas c 503 analytical unit.Discrepant results were provided for 1 patient sample tested for glucose hk gen.3.The initial result from the(b)(6) analyzer was 35 mg/dl.As this result did not correspond to the patient¿s clinical history, a capillary test was performed and the glucose result was 80 mg/dl.The original sample was repeated on the (b)(6) analyzer with a result of 78 mg/dl.The questionable result was not reported outside of the laboratory.The repeat result was believed to be correct.

• 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: 18582523
• Report Number: 1823260-2024-00229
• Device Sequence Number: 8247084
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• PMA/510(K) Number: K191899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2024

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: 01/15/2024
• Initial Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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