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

Model Number	C503
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the crep2 (creatinine plus ver.2) assay on a cobas c 503 analytical unit.The sample initially resulted in a crep2 value of 86.2 mol/l and repeated as 60.1 mol/l.The initial questionable result was reported outside of the laboratory.The crep2 reagent lot was 67171801 with an expiration date of (b)(6)2023.
Additional Manufacturer Narrative
The alleged blood sample was run after a urine sample with a crep2 value of 30.4 mmol/l indicating possible contamination between the samples.It is not known if the urine sample derives from the same patient.Upon review of the alarm trace, several abnormal aspiration alarms were observed.These are indicators for a possible pre-analytical sample handling issue.The field service engineer checked the analyzer and found a dirty sample probe.After replacing the sample probe, the issue did not re-occur.The analyzer was confirmed to be running back within specifications.The investigation did not identify a product problem.The issue is consistent with a pre-analytical handling issue.

• 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: 16374958
• Report Number: 1823260-2023-00459
• Device Sequence Number: 6926966
• Product Code: JJE
• UDI-Device Identifier: 07613336121160
• UDI-Public: 07613336121160
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/20/2023

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: 01/18/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/20/2023
• 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