MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Catalog Number 08469890160

Device Problem Low Test Results (2458)

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

Event Date 12/02/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys troponin t assay results for 1 patient sample on a cobas e 801 analytical unit.The initial troponin result was 29.3 ng/l.The doctor questioned the result as it did not match the patient's previous result and the sample was repeated.The sample was repeated the next day on another e801 analyzer and the result was 90 ng/l.The repeat result was deemed correct.

Manufacturer Narrative

The reagent lot number is 68815101 and the expiration date is 30-apr-2024.The field service engineer (fse) performed rinse and mechanism checks and performed a 21 cup precision test successfully.The fse stated that the patient sample appeared lipemic and turbid.The investigation is ongoing.

Manufacturer Narrative

Calibration was last performed on 24-oct-2023.The qc recovery data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.No product problem was identified.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: ELECSYS TROPONIN T GEN 5
• Type of Device: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18347461
• MDR Text Key: 331066855
• Report Number: 1823260-2023-04082
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 07613336158982
• UDI-Public: 07613336158982
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K201441
• 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
• Report Date: 01/23/2024
• 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 Expiration Date: 04/30/2024
• Device Catalogue Number: 08469890160
• Device Lot Number: 68815101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/23/2024
• 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
• Patient Age: 66 YR
• Patient Sex: Male