MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05168449190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reagent lot number and expiration date were requested but were not provided.The field service engineer found issues with the rinse station tubing, the gear pump pressure, and the rinse station wash.He replaced the tubing and gear pump head.The investigation did not identify a specific product problem.The issue was resolved by the service actions.
Event or Problem Description
There was an allegation of a questionable calcium gen.2 result for one patient sample from the cobas 8000 c702 module.The initial result was 1.84 mmol/l.As the result did not fit the patient history or accompanying po4 and vitamin d results, the sample was repeated with a result of 2.44 mmol/l.

• Brand Name: COBAS 8000 C 702 MODULE
• 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 46250-0457
• MDR Report Key: 18978533
• Report Number: 1823260-2024-00903
• Device Sequence Number: 6639018
• Product Code: JJE
• UDI-Device Identifier: 04015630924936
• UDI-Public: 04015630924936
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K113521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2024

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: 05168449190
• Device Lot Number: 17U1-09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 03/26/2024
• 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