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

Catalog Number 09315357190

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

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

Event Date 05/16/2023

Event Type  malfunction  

Manufacturer Narrative

An instrument check was performed and all tests passed.Upon review of the alarm trace, there were no sample-related alarms around the time the patient sample was pipetted.The alarm trace showed multiple sample foam detection alarms, sample clot, and sample short alarms occurring between may 2023 and 05-jun-2023.The investigation could not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys troponin t hs on cobas e 801 analytical unit serial number (b)(6).The sample initially resulted in a troponin t value of 10.5 ng/l and this value was reported outside of the laboratory.The doctor questioned the result as it was inconsistent with the patient's previous result.The doctor requested a repeat of the sample.The sample was repeated, resulting in a troponin t value of 4025 ng/l.The sample was also repeated on a second e 801 analyzer, resulting in a troponin t value of 3996 ng/l.

• 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: 17100347
• MDR Text Key: 317829568
• Report Number: 1823260-2023-01922
• 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
• Report Date: 06/09/2023

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 Catalogue Number: 09315357190
• Device Lot Number: 642405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/09/2023
• 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