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

Model Number	C503
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reaction monitor curve for the initial result was abnormal.The reaction monitor curves for the repeat results were normal.Calibration was last performed on (b)(6) 2022 with acceptable results.Qc was acceptable."abnormal aspiration" and "sample short" alarms were observed on the customer¿s alarm trace data from the day of the event.The customer used 13 mm sample tubes with no rack adapter.The investigation is ongoing.Na.
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for cholesterol gen.2 (chol2) on a cobas pro c 503 analytical unit.The initial result was 15.5 mmol/l.On (b)(6) 2022 the sample was repeated with results of 7.72 mmol/l and 7.68 mmol/l.The questionable high result was not reported outside of the laboratory.The chol2 reagent lot number was 658312 with an expiration date of 31-may-2023.
Additional Manufacturer Narrative
The analyzer was maintained properly.The customer was using the 13 mm tubes without rack adapters and alarm trace has several sample short alarms on the day of the event.A general reagent issue was ruled out since calibration and qc data were performed and they passed.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.No product issue was found.

• 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: 16102239
• Report Number: 1823260-2023-00058
• Device Sequence Number: 7608026
• Product Code: JJE
• UDI-Device Identifier: 07613336121115
• UDI-Public: 07613336121115
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 03/03/2023

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: 12/13/2022
• Supplement Date Received by Manufacturer: 01/12/2023; 02/02/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/26/2023; 03/03/2023
• 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