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

Catalog Number 09315357190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 06/06/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.Based on the available data, a general reagent issue could be excluded.The alarm trace showed one sample clot detection, 7 abnormal aspiration, and 5 sample short alarms.An instrument check was performed on 16-jun-2023 and was acceptable.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys troponin t hs assay results for 2 patient sample on a cobas e 801 module.On (b)(6) 2023, patient 1 had an initial troponin result of 109 pg/ml.The result was reported outside of the laboratory and the patient was sent to the emergency room.A new sample was collected and the result was 7 pg/ml.The original sample was repeated and the troponin result was 7.00 pg/ml.The repeat result was deemed correct.The patient did not receive further treatment and was discharged from the emergency room.On (b)(6) 2023, patient 2 had an initial troponin result of 9.97 pg/ml.The sample was repeated twice and the results were 37.5 pg/ml and 37.7 pg/ml.The repeat results were deemed correct.

Manufacturer Narrative

Based on the available data, a general reagent issue could be excluded.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: ELECSYS TROPONIN T HS
• 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: 17269589
• MDR Text Key: 319101991
• Report Number: 1823260-2023-02182
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/31/2023

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: 11/30/2023
• Device Catalogue Number: 09315357190
• Device Lot Number: 64240501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/31/2023
• 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