MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T HS STAT; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Catalog Number 09315349190

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with elecsys troponin t hs stat on a cobas e411 rack and a cobas 6000 e 601 module.The first sample initially resulted in a troponin t value of < 3 pg/ml when tested on the e411 analyzer.When repeated on the e601 analyzer, the troponin t result was 7.2 pg/ml.The second sample initially resulted in a troponin t value of 11.9 pg/ml when tested on the e411 analyzer.When repeated on the e601 analyzer, the troponin t result was 15.6 pg/ml.The third sample initially resulted in a troponin t value of 13.4 pg/ml when tested on the e411 analyzer.When repeated on the e601 analyzer, the troponin t result was 17.81 pg/ml.

Manufacturer Narrative

The serial number of the e411 analyzer is (b)(6).Al number of the e601 analyzer was requested, but not provided.The field service engineer replaced the sample probe on the e411 analyzer.The first level calibrator signals were within expectations.The second level calibrator signals were lower than expected.The customer provided five patient samples for investigation.Investigations of these samples found no result discrepancy between the e601 and e411 platforms.The investigation is ongoing.

Manufacturer Narrative

The field service engineer performed preventive maintenance on the analyzer.No further issues occurred after this action.The investigation determined the issue was resolved by the service actions and is consistent with inadequate analyzer maintenance.

Manufacturer Narrative

The customer installed the troponin t assay onto a second e411 analyzer and performed parallel testing of the same three samples on it and the original e411 and e 601 module analyzers.The serial number of the second e411 analyzer was requested, but not provided.Sample 1 troponin t results: e601 = 10.13 pg/ml.E411 = 5.29 pg/ml.Second e411 = 7.2 pg/ml.Sample 2 troponin t results: e601 = 24.7 pg/ml.E411 = 21.11 pg/ml.Second e411 = 22.95 pg/ml.Sample 3 troponin t results: e601 = 10.98 pg/ml.E411 = 5.56 pg/ml.Second e411 = 8.73 pg/ml.

• Brand Name: ELECSYS TROPONIN T HS STAT
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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 46250-0457
• MDR Report Key: 18326523
• MDR Text Key: 330498217
• Report Number: 1823260-2023-03992
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: GR
• 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,Followup,Followup
• Report Date: 04/01/2024
• 2 Devices were Involved in the Event: 1 2

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: 09315349190
• Device Lot Number: 72612601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 02/01/2024
• Supplement Dates FDA Received: 01/12/2024; 04/01/2024
• 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