MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (DISK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Catalog Number 04775279001

Device Problem Low Test Results (2458)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

The pth reagent lot number is 722328.The psa reagent lot number was not provided.The expiration dates were not provided.The calibration data provided was acceptable.The field service engineer (fse) decontaminated and adjusted the sample and sipper probes.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

Event Description

There was an allegation of questionable elecsys pth immunoassay and elecsys total psa results for 2 patient samples on a cobas e 411 immunoassay analyzer.The customer was prompted to repeat the samples as their qc was out of range and after repeating the qc and obtaining acceptable results, they repeated previously run patient samples.For sample 1, the initial psa result was 0.006 ng/ml with flag.The sample was repeated and the repeat result was 0.269 ng/ml.For sample 2, the initial pth result was 2.40 pg/ml with flag.The sample was repeated and the repeat result was 43.87 pg/ml.

• Brand Name: COBAS E 411 ANALYZER (DISK SYSTEM)
• 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: 19043675
• MDR Text Key: 340115163
• Report Number: 1823260-2024-01043
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (y/n): Y
• Reporter Country Code: RO
• PMA/PMN Number: K961481
• 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
• Report Date: 04/04/2024

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: 04775279001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/04/2024
• 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