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

Catalog Number 07398000160

Device Problems Mechanical Problem (1384); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t stat assay on a cobas e411 rack.The sample initially resulted in a troponin t value of < 6 ng/l accompanied by a data flag.The doctor questioned the result and the sample was repeated.The repeat result was 29 ng/l.The repeat value was deemed correct and a corrected report was issued.

Manufacturer Narrative

The serial number of the e411 analyzer is (b)(6).The investigation is ongoing.

Manufacturer Narrative

The last calibration performed on 10-oct-2023 was ok and there were no alarms.Quality controls recovered outside of range low.The field service engineer checked the mixer adjustment and re-adjusted the mixer.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• 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: 18134006
• MDR Text Key: 328121230
• Report Number: 1823260-2023-03609
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2023
• 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: 07398000160
• Device Lot Number: 672042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/17/2023; 12/13/2023
• Supplement Dates FDA Received: 12/11/2023; 12/15/2023
• 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
• Patient Age: 73 YR
• Patient Sex: Male