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 08/06/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The calibration and qc data provided was acceptable.Based on the calibration and qc data, a general reagent issue could be excluded.The field service engineer (fse) adjusted a probe and performed mechanical checks successfully.The fse also found electrical issues at the customer site.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys troponin t hs stat assay results for 1 patient sample on a cobas e 411 immunoassay analyzer.On (b)(6) 2023, the initial troponin result was 0.048 ng/ml.Another sample was collected that gave a "negative" result, which prompted the customer to repeat the sample.A plasma sample was repeated and the result was 0.004 ng/ml.A serum sample was repeated and the result was less than 0.003 mg/ml.On (b)(6) 2023, another plasma sample was repeated an the result was 0.003 ng/ml.Another serum sample was also repeated and the result was less than 0.003 mg/ml.Clarification on if the plasma and serum samples were all collected at the same time or were aliquot samples was not provided.

Manufacturer Narrative

The alarm trace did not contain a conspicuous event.The investigation did not identify a product problem.The root 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17682853
• MDR Text Key: 322631215
• Report Number: 1823260-2023-02879
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: CO
• PMA/PMN Number: K201441NA
• 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: 10/13/2023

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 09315349190
• Device Lot Number: 68812403
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 10/13/2023
• 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