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

Model Number	C502
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer checked the analyzer; there were no abnormalities.Precision testing was performed and passed successfully.The customer ran quality control successfully.The investigation could not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the trsf2 (tina-quant transferrin ver.2) assay on a cobas 8000 c 502 module.The sample initially resulted in a trsf2 value of 195 mg/dl.The sample was repeated on (b)(6) 2023, resulting in a value of 248 mg/dl.The repeat result was deemed correct.The initial questionable result was reported outside of the laboratory.The trsf2 reagent lot was 63631201 with an expiration date of 31-mar-2024.

• Brand Name: COBAS 8000 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16308604
• Report Number: 1823260-2023-00373
• Device Sequence Number: 6792451
• Product Code: JJE
• UDI-Device Identifier: 04015630917419
• UDI-Public: 04015630917419
• Combination Product (Y/N): N
• 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): 02/06/2023

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: C502
• Device Catalogue Number: 05964067001
• 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: 01/12/2023
• Initial Report FDA Received Date: 02/06/2023
• 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