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

Lot Number 68812400

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

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

Event Date 04/03/2023

Event Type  malfunction  

Manufacturer Narrative

Na h3 other text : na.

Event Description

The initial reporter received a questionable elecsys troponin t hs stat result from one patient sample tested on the cobas 8000 - cobas e 602 module with serial number (b)(6).The initial result was reported outside of the laboratory.The medical personnel asked for clarification regarding the reported result because it was not aligned with the (b)(6)2023 at 8:19 pm result of 48.29 pg/ml.The patient sample was rerun on the module and another module.On (b)(6) 2023 at 11:38 pm, the initial result from the module was 7.07 pg/ml.On (b)(6) 2023 at 12:16 am, the first repeat result from the other module was 40.80 pg/ml.On (b)(6) 2023 at 12:44 am, the second repeat result from the module was 41.53 pg/ml.

Manufacturer Narrative

The last calibration performed on (b)(6) 2023 was within specifications.The customer uses third-party qc.Data from calibration and qc do not point to a general reagent or instrument problem.The alarm trace from (b)(6) 2023 8:20 pm until (b)(6) 2023 4:41 am did not indicate any issues.The patient sample was centrifuged for 10 minutes at 2400 x g.The centrifugation recommendations from the tube supplier are 1300 - 2000 x g for 10 min or 3000 x g for 5 minutes.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• 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: 16848478
• MDR Text Key: 314386387
• Report Number: 1823260-2023-01471
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/23/2023

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 Expiration Date: 05/31/2024
• Device Lot Number: 68812400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/23/2023
• 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 Sex: Male