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

Catalog Number 09315349190

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

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2022, a repeatability test for the assay was performed with acceptable results.

Event Description

The initial reporter received a questionable elecsys troponin t stat assay ver.2.1 result for one patient sample tested on a cobas e411 rack with serial number (b)(4) the initial result was reported outside of the laboratory.The patient's sample was rerun on a cobas h232 and a cobas e601.On (b)(6) 2022 at 5:30 pm, the initial result from the analyzer was 15.4 ng/l.The repeat result from cobas h232 was 182 ng/l.On (b)(6) 2022, the repeat result was 132.7 ng/l.The repeat result from the cobas e601 was 129.7 ng/l.The correct result was reported to be the positive result of about 130 ng/l or 180 ng/l on the cobas h232.

Manufacturer Narrative

The calibration performed on (b)(6) 2022 did not indicate an issue.The qc recovery is within -2sd.There is no indication for a performance issue of the reagent or instrument.Pre-analytical data were requested but not provided.The alarm trace did not indicate an issue.The investigation did not identify a general instrument or reagent problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13825265
• MDR Text Key: 294391006
• Report Number: 1823260-2022-00760
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 04/14/2022

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: 09315349190
• Device Lot Number: 530939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/14/2022
• 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