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 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys troponin t hs results for 3 patient samples on a cobas e 801 module.Sample 1: the initial result was 373 ng/l and the repeated result was 6.20 ng/l.The sample was repeated on a different line and the results were 10.30 ng/l and 8.33 ng/l.Sample 2: on (b)(6) 2024 the initial result was 378 ng/l.The sample was sent to another site and the result was 11 ng/l.Sample 3: on (b)(6) 2024 the initial result was 4.5 ng/l.The repeated results were 9.9 ng/l and 4.7 ng/l.The sample was respun and the result was 3.3 ng/l.

Manufacturer Narrative

Calibration signals were lower than expected.No controls were measured prior to the sample measurement on (b)(6) 2024 per product labeling, controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per cobas e pack, and following each calibration.Images of one sample showed issues with sample quality.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18659423
• MDR Text Key: 334761678
• Report Number: 1823260-2024-00356
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K201441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• 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: 09315357190
• Device Lot Number: 688155
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2024
• 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