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

Catalog Number 09315322190

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

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e602 analyzer is (b)(6).Calibration and controls were acceptable.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys troponin t hs on a cobas 8000 e 602 module.The sample initially resulted in a troponin t value of 13.41 ng/l.The sample was repeated twice on a second analyzer, resulting in troponin t values of 265 ng/l and 264 ng/l.

Manufacturer Narrative

The field service engineer found the sample probe tip was dirty and covered in dried serum.He also noticed a black unknown substance came out of the probe.He replaced the probe.Based on these findings, the investigation determined the issue was due to pre-analytical handling issues at the customer site and insufficient user maintenance.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.A general reagent problem was not present, because the qc before the event was within ranges.

• 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: 19142320
• MDR Text Key: 341461859
• Report Number: 1823260-2024-01212
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K961500
• 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
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09315322190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• 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