MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Catalog Number 07682913001

Device Problems Leak/Splash (1354); Non Reproducible Results (4029)

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

Event Date 02/12/2024

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for approximately 40 patient samples tested with elecsys vitamin d total ii on a cobas e 801 module.Examples of data are provided for five patient samples with discrepant vitamin d results.The first sample initially resulted in a vitamin d value of 101 ng/ml and it repeated as 29.80 ng/ml.The second sample initially resulted in a vitamin d value of 107 ng/ml and it repeated as 45.20 ng/ml.The third sample initially resulted in a vitamin d value of > 120 ng/ml and it repeated as 29.20 ng/ml.The fourth sample initially resulted in a vitamin d value of > 120 ng/ml and it repeated as 32.90 ng/ml.The fifth sample initially resulted in a vitamin d value of > 120 ng/ml and it repeated as 25.50 ng/ml.

Manufacturer Narrative

The vitamin d reagent lot number and expiration date were requested, but not provided.The field service engineer found damaged tubing.The tubing was replaced and this resolved the issue.The investigation is ongoing.

Manufacturer Narrative

The alarm trace showed several alarms indicating a malfunction/leakage of a systems reagent or usage of one channel of the system reagent only.The field service engineer replaced a radio frequency id reader.The system reagent tube lifter was also replaced and this resolved the issue.The investigation determined the issue was resolved by the service actions and was caused by leakage at the tube lifter.

• Brand Name: COBAS 8000 E 801 MODULE
• Type of Device: IMMUNOCHEMISTRY 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: 18787847
• MDR Text Key: 336324980
• Report Number: 1823260-2024-00555
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): Y
• Reporter Country Code: BE
• PMA/PMN Number: K060373
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07682913001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• 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