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

Catalog Number 09315349190

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

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

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

The e411 analyzer serial number was (b)(6).

Event Description

The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys troponin t hs stat (troponin t hs stat) on a cobas e 411 analyzer (rack system).The initial result was 140 pg/ml.A new sample was obtained 2 hours later and the result was <3.00 pg/ml with a data flag.This sample was repeated with a result of 141.9 pg/ml with a data flag.

Manufacturer Narrative

The customer did not provide any further information for the investigation.Due to the limited information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

Manufacturer Narrative

The investigation findings and investigation conclusion codes were updated.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17905946
• MDR Text Key: 325300145
• Report Number: 1823260-2023-03245
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K201441NA
• 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: 10/25/2023

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: 09315349190
• Device Lot Number: 72612601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 10/25/2023
• Supplement Dates FDA Received: 10/23/2023; 10/25/2023
• 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