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 04/28/2023

Event Type  malfunction  

Manufacturer Narrative

Last calibration was performed on (b)(6) 2023 and it was acceptable.Investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with elecsys troponin t hs (tnths) stat assay on a cobas e411 immunoanalyzer serial number (b)(6).On (b)(6) 2023: the original sample was tested on cobas e411 and gave an initial result of 14.83 pg/ml.It is unknown if the questionable result was reported outside the laboratory.A 2nd sample was withdrawn and tested on cobas 6000 e601.It gave a result of 217.3 ng/l and a repeat result of 219.9 ng/l.The original sample was re-tested on cobas 6000 e601 and gave a result of 216.3 ng/l.On 28-apr-23 the 2 samples were rerun on the cobas e411: the original sample gave a rerun result of 216.7 pg/ml and the 2nd sample gave a rerun result of 221.3 pg/ml.The correct result was 216.7 pg/ml.

Manufacturer Narrative

The customer was not using rack adapters with 13 mm tubes.From the data provided a general reagent issue can be excluded.The investigation did not identify a product 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17001458
• MDR Text Key: 315916828
• Report Number: 1823260-2023-01744
• 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: 06/22/2023

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: 688124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/22/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male