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

Catalog Number	08463662001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number was 750240 and the expiration date was not provided.Customer material was requested for investigation.No issues were identified during a review of the alarm trace data.Sample probe cleaning was performed as part of troubleshooting.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable magnesium (mg2) results for one patient sample tested on a cobas c 503 module.The initial magnesium result was 1.44 mmol/l and the repeat results were 0.796 mmol/l and 0.784 mmol/l.The questionable result was not reported outside the laboratory.The repeat result was believed to be correct.
Additional Manufacturer Narrative
The requested customer material, a laboratory water sample, was not returned for investigation.Contamination of the probe was not excluded as the troubleshooting did not solve the issue.The field service engineer performed all adjustments and the sample probe was exchanged.The investigation determined that the issue is consistent with insufficient maintenance and the service actions resolved the 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18650181
• Report Number: 1823260-2024-00334
• Device Sequence Number: 17920182
• Product Code: JJE
• UDI-Device Identifier: 07613336158784
• UDI-Public: 07613336158784
• Combination Product (Y/N): Y
• 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): 03/01/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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