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 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

The reagent lot number was 73281801 with an expiration date of 31-dec-2024.The field service engineer found valves needed adjustments which he performed.He ran checks that verified the analyzer performance.The investigation determined the service actions resolved the issue.

Event Description

There was an allegation of questionable ast results from the cobas 8000 c702 module.The samples were repeated on the same analyzer and then repeated on another cobas analyzer.Sample 1 initial result was 25 u/l with a data flag and the repeat results were 7 u/l and 31 u/l.Sample 2 initial result was 29 u/l with a data flag and the repeat results were 14 u/l and 36 u/l.Sample 3 initial result was 30 u/l with a data flag and the repeat results were 12 u/l and 37 u/l.Sample 4 initial result was 10 u/l with a data flag and the repeat results were 7 u/l and 31 u/l.Sample 5 initial result was 45 u/l with a data flag and the repeat results were 7 u/l and 31 u/l.The repeat result from the other analyzer was believed correct.

• 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: 18846722
• MDR Text Key: 337006509
• Report Number: 1823260-2024-00665
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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
• Date Manufacturer Received: 02/08/2024
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 109 KG