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

Catalog Number 09315349190

Device Problem Low Test Results (2458)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

The initial reporter stated they received a questionable result for one patient sample tested with elecsys troponin t hs stat on a cobas e411 rack.The result did not agree with the patient's clinical history.The following troponin i results were from a different laboratory: on (b)(6) 2024 the troponin i result from a siemens advia centaur analyzer was 577.48 ng/l.On (b)(6) 2024 the troponin i result from a siemens advia centaur analyzer was 1045 ng/l.On (b)(6) 2024 the troponin i result from a siemens advia centaur analyzer was 1331 ng/l.On (b)(6) 2024 the troponin t hs result from the e411 instrument was 12.13 pg/ml.The patient has acute coronary syndrome (act) and the customer expected a higher result.On (b)(6) 2024 the troponin i result from a siemens atellica analyzer was 2935 ng/l.On (b)(6) 2024 the troponin t hs result from the e411 instrument was 52.30 pg/ml.

Manufacturer Narrative

The e411 analyzer serial number is (b)(6).The patient's sample was requested for investigation.The investigation is ongoing.

• Brand Name: ELECSYS TROPONIN T HS STAT
• 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: 19174959
• MDR Text Key: 341261246
• Report Number: 1823260-2024-01262
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: LO
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09315349190
• Device Lot Number: 74311500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• 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
• Treatment: ANOPYRIN 100 MG 1X/DAY; BELOC ZOK 50MG 1X/DAY; CO-PRENESSA 4/1.25 MG 1X/DAY; MEDOSPIR 25 MG HALF TAB/DAY; PRENESSA 4MG HALF TAB/DAY
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White