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

Catalog Number 08469814190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with elecsys troponin t hs stat on a cobas e411 disk.No questionable results were reported outside of the laboratory.The first patient sample initially resulted in a troponin t value of 4706 ng/l.The sample was repeated twice, resulting in values of 26 ng/l and 4856 ng/l.The values of 4706 ng/l and 4856 ng/l were deemed correct.The second patient sample initially resulted in a troponin t value of 15 ng/l on (b)(6) 2023.The sample was repeated on (b)(6) 2023, resulting in a value of 41 ng/l.The repeat value was deemed correct.

Manufacturer Narrative

The serial number of the cobas e411 disk is (b)(6).The field service engineer checked the system.Probe tubing, the measuring cell, syringe seals, and tubing seals were replaced.The probes and mixer were cleaned and adjusted.The photomultiplier tube high voltage was adjusted.The system volume was checked, a blank cell calibration was performed, and performance testing was run.Calibration and controls were run.

Manufacturer Narrative

There were no indications for issues based on calibration and control data.The investigation could not identify a product problem.The cause of the event could not be determined.The issue was resolved after the service actions were performed.

• 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): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17336822
• MDR Text Key: 319475299
• Report Number: 1823260-2023-02284
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K201441
• 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: 08/22/2023

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: 08469814190
• Device Lot Number: 634809
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male