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

Catalog Number 06473245001

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2024

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with phos2 (phosphate) on a cobas 8000 c 702 module.The first sample initially resulted in a phosphate value of < 0.2 mmol/l and then repeated as 0.17 mmol/l.The sample was repeated twice, resulting in values of 1.28 mmol/l and 1.26 mmol/l.The second sample initially resulted in a phosphate value of 0.01 mmol/l on 09-mar-2024.The sample was repeated twice on 09-mar-2024, resulting in values of 1.20 mmol/l and 1.20 mmol/l.

Manufacturer Narrative

The phosphate reagent lot number and expiration date were requested, but not provided.The investigation is ongoing.

Manufacturer Narrative

Reagent issues were excluded as the customer had no further issues and the correct repeat result was received using the same reagent.On 03-apr-2024 the field service engineer (fse) replaced the gear pump head, the solenoid valve, and the degasser and choke.As multiple parts were replaced, the specific cause of the event could not be determined.The investigation determined the event was due to a maintenance issue.

• Brand Name: COBAS 8000 C 702 MODULE
• Type of Device: 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: 18980060
• MDR Text Key: 338619620
• Report Number: 1823260-2024-00913
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male