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	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested for k, bun, and crej2 assays.On (b)(6)2023 at 6:27 p.M.The customer ran the sample and received the initial results: k result: 6.5 mmol/l, bun result: 37 mg/dl, crej2 result: 8.9 mg/dl.The initial results were reported outside of the laboratory where the physician questioned the bun result and the laboratory reran the sample.The customer reran the sample and received the following results: k result: 5.0 mmol/l, bun result: 20 mg/dl, crej2 result: 3.0 mg/dl.This medwatch will apply to bun and crej2 assays from the cobas pro c503 analytical unit.Please refer to medwatch with a1 patient identifier (b)(4) for information related to k results from the cobas pro ise analytical unit.The lot number of the bun reagent used was 663424.The lot number of crej2 reagent used was 567564.The expiration date of both reagents was not provided.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6)2023 with acceptable results.Qc was acceptable."abnormal reagent flow path", "abnormal aspiration" and multiple sample alarms were observed on the alarm trace data.The field service engineer (fse) did not find a cause for the issue.The fse replaced the sample probe and performed checks on the fluidics.Mechanical and operational checks passed.The investigation did 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: 16500147
• Report Number: 1823260-2023-00719
• Device Sequence Number: 16969470
• Product Code: JJE
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• 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
• Report Date (Section B): 03/07/2023

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: 02/08/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female