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

Catalog Number	08463662001
Medical Device Problem Codes	Unable to Obtain Readings (1516); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's plasma sample tested with glucose hk gen.3 (gluc3) assay on a cobas pro c503 analyzer when compared to a different cobas pro c503 analyzer.Initial result: 8 mg/dl.The customer noticed that the result was low and re-tested the sample.Repeat result: 30 mg/dl (tested on another c503).The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The gluc3 reagent lot number and expiration date were not provided.The calibration for gluc3 was last performed on 12-jan-2024 and it was acceptable.Qc recovery was within acceptable range.The alarm trace did not show any abnormality.The field service engineer found a build-up on the sample probe.He adjusted the rinse levels in the cuvettes, replaced the sample probes, and performed adjustments.Precision studies were performed and they were within specifications.The customer performed qc and it was successful.The service actions (adjusting the rinse levels in the cuvettes, replacing the sample probes, and performing adjustments) resolved the issue.No further issues were reported afterward.

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18705441
• Report Number: 1823260-2024-00441
• Device Sequence Number: 20215009
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 02/14/2024

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 Catalogue Number: 08463662001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 02/14/2024
• 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: Male