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

Catalog Number 07398000160

Device Problem Low Test Results (2458)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The field service engineer (fse) ran a 21 cup precision test and mechanical and performance checks successfully.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys troponin t hs assay results for 1 patient sample on a cobas e 411 immunoassay analyzer.The initial troponin result was 14.87 ng/l.Another sample was collected from the patient that gave a result of 66.41 ng/l which prompted the customer to repeat the previous sample.The initial sample was repeated and the result was 66.92 ng/l.The repeat result was deemed correct.

Manufacturer Narrative

Calibration was last performed on (b)(6) 2023.The calibration and qc recovery data provided was acceptable.The alarm trace did not contain a conspicuous event.No product problem was identified.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• 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: 17998273
• MDR Text Key: 326462520
• Report Number: 1823260-2023-03416
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K051752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

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: 07398000160
• Device Lot Number: 726135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/30/2023
• 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