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

Model Number	C503
Medical Device Problem Codes	Chemical Problem (2893); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the tp2 (total protein gen.2) assay on a cobas c 503 analytical unit.The sample initially resulted in a tp2 value of 0.3 g/dl, accompanied by a data flag.The sample was reported outside of the laboratory and questioned.The sample was repeated resulting in a value of 7.0 g/dl, which was deemed correct.The tp2 reagent lot was 63565201 with an expiration date of 31-jul-2023.
Additional Manufacturer Narrative
Reportedly the calibration and quality controls were acceptable at the time of testing.The customer was concerned the result had a "hu" data flag.Per product labeling: "hu - alarm: higher uncertainty, description: the result lies between the limit of detection (lod) and the limit of quantitation (loq)., cause: the sample concentration is too low., remedy: 1.For specific c 503 tests: repeat the test with increased sample volume, if available for the test.Check the sample volumes on menu > application.2.For ise and c 503 tests: perform maintenance > 18 sample probe wash.3.Repeat the test with a new aliquot." the customer did not provide any additional information for the investigation.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 16388841
• Report Number: 1823260-2023-00481
• Device Sequence Number: 17421838
• Product Code: JJE
• UDI-Device Identifier: 07613336121528
• UDI-Public: 07613336121528
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: 01/19/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 04/03/2023
• 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