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

Model Number	C503
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer found fibrin on the sample probe.The probe was cleaned and probe wash maintenance was performed.After this, controls were run and were ok.
Event or Problem Description
The initial reporter stated they received discrepant results for an unspecified number of patient samples tested on the cobas c 503 analytical unit.The reporter provided questionable data for one patient sample tested with chol2 cholesterol gen.2 and ten patient samples tested with gluc3 glucose hk gen.3 on a cobas c 503 analytical unit.No incorrect results were reported outside of the laboratory.Refer to the attachment for all patient data.The samples were initially tested on the complained c 503 analyzer and they were repeated on a second analyzer.The glucose reagent lot number was 643503, with an expiration date of 31-aug-2023.The cholesterol reagent lot number was 658312, with an expiration date of may 2023.
Additional Manufacturer Narrative
The field service engineer checked the cell rinse unit and cell rine water volume.Adjustments were made to the volume and the degasser was replaced.The system software was also upgraded.Precision testing and quality controls were performed and were acceptable.The specific root cause could not be determined.The issue appeared to be resolved after the service actions.

• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16129887
• Report Number: 1823260-2023-00094
• Device Sequence Number: 16957271
• Product Code: JJE
• UDI-Device Identifier: 07613336121283
• UDI-Public: 07613336121283
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 02/23/2023

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 Model Number: C503
• Device Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/23/2023
• 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