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 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys troponin t hs assay results for 5 patient samples on 3 cobas e 801 analytical units with serial numbers (b)(6), (b)(6), and (b)(6).The initial results were reported outside of the laboratory.The customer was performing all troponin testing in duplicate due to previous issues.For sample 1, the initial troponin result was 15.2 pg/ml on analyzer serial number (sn) (b)(6).The repeat result was 21.5 pg/ml on analyzer sn (b)(6).For sample 2, the initial troponin result was 759 pg/ml on analyzer sn (b)(6).The repeat result was 944 pg/ml on analyzer sn (b)(6).For sample 3, the initial troponin result was 593 pg/ml on analyzer sn (b)(6).The repeat result was 733 pg/ml on analyzer sn (b)(6).For sample 4, the initial troponin result was 654 pg/ml on analyzer sn (b)(6).The repeat result was 799 pg/ml on analyzer sn (b)(6).For sample 5, the initial troponin result was 22.4 pg/ml on analyzer sn (b)(6).The repeat result was 27.1 pg/ml on analyzer sn (b)(6).

Manufacturer Narrative

Calibration was last performed on (b)(6) 2023.The qc recovery data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.The alarm trace showed several sample clot, sample short, sample foam, and abnormal aspiration alarms across all three analyzers.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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: 16975379
• MDR Text Key: 315691727
• Report Number: 1823260-2023-01703
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/25/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• 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