MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 IMMUNOASSAY ANALYZER; IMMUNOCHEMISTRY ANALYZER

Model Number E411 RACK

Device Problems Circuit Failure (1089); High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 08/08/2021

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for six patient samples tested with elecsys tacrolimus on a cobas e 411 immunoassay analyzer.The initial values were reported outside of the laboratory to the doctor.The doctor questioned the results as they did not correspond to the clinical history of the patients, so the samples were repeated on a second analyzer.The first sample initially resulted in a tacrolimus value of 25.2 ng/ml, which repeated as 11.8 ng/ml.The second sample initially resulted in a tacrolimus value of 9.1 ng/ml, which repeated as 2.7 ng/ml.The third sample initially resulted in a tacrolimus value of 8.5 ng/ml, which repeated as 3.2 ng/ml.The fourth sample initially resulted in a tacrolimus value of 29.5 ng/ml, which repeated as 10 ng/ml.The fifth sample initially resulted in a tacrolimus value of 20.3 ng/ml, which repeated as 13.7 ng/ml.The sixth sample initially resulted in a tacrolimus value of 20.5 ng/ml, which repeated as 11.7 ng/ml.The lot number and expiration date of the tacrolimus reagent were requested, but not provided.

Manufacturer Narrative

The field service engineer replaced the detection unit since the photomultiplier signal was unstable.Performance testing was run and precision was within specification.Controls run prior to the affected samples was acceptable, but controls run after running the patient samples were out of range.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS E 411 IMMUNOASSAY ANALYZER
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12383975
• MDR Text Key: 268681867
• Report Number: 1823260-2021-02518
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630924721
• UDI-Public: 04015630924721
• Combination Product (y/n): N
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E411 RACK
• Device Catalogue Number: 04775201001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1