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

Catalog Number 09315349190

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 09/21/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e 601 module serial number was (b)(6).Two samples were submitted for investigation.One of the samples was tested with troponin t hs stat reagent lot 688124 on a cobas e601 module and a cobas e411 analyzer: the result from the e601 module was 6.57 pg/ml.This result is higher than the customer¿s results of <3 pg/ml.The result from the e411 analyzer was 16.95 pg/ml.This result is slightly lower than the customer¿s results of approximately 20 pg/ml.The investigation is ongoing.

Event Description

The initial reporter questioned low results for 1 patient tested for elecsys troponin t hs stat (troponin t hs stat) on a cobas e 601 module.Two samples from the patient were tested on a cobas e411 instrument and the e601 module on different days.The results for both samples on the e411 instrument were approximately 20 pg/ml.The same samples were run on the e601 module with results of <3pg/ml.Note: it is not clear which of the following results run on the e411 instrument and the e601 module were from the same sample.On (b)(6) 2023 the result from the e411 instrument was 20.79 pg/ml.On (b)(6) 2023 the result from the e411 instrument was 23.26 pg/ml.On (b)(6) 2023 the results from the e601 module were <3pg/ml and <3pg/ml.On (b)(6) 2023 the result from the 411 instrument was 20.05 pg/ml.On (b)(6) 2023 the results from the e601 module were <3pg/ml and <3pg/ml.On (b)(6) 2023 the result from the e411 instrument was 20.26 pg/ml.On (b)(6) 2023 the results from the e601 module were <3pg/ml and <3pg/ml.On (b)(6) 2023 the results from the e411 instrument were 20.33 pg/ml and 19.13 pg/ml.On (b)(6) 2023 the results from the e601 module were <3pg/ml and <3pg/ml.On (b)(6) 2023 the results from the e411 instrument were 20.07 pg/ml and 19.49 pg/ml.An interference is suspected for this patient as other patient samples were run on both instruments and the results were similar.

Manufacturer Narrative

Calibration and qc data do not suggest an issue.No instrument issues were identified.The customer's results were reproduced during the investigation.The bead pattern of one sample was investigated further and compared to reference samples where there was a homogenous distribution of beads inside the measuring cell.For this patient sample, strong bead aggregation was observed.The patient sample was tested with a different assay (tsh) for comparison purposes and a homogenous bead distribution was observed.The low results produced by the e601 instrument were due to an interfering factor that caused bead aggregation and therefore signal quench.The concentration of the patient's sample thus showed low results.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte specific antibodies, streptavidin or ruthenium can occur." the investigation did not identify a product problem.

• 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: 17967643
• MDR Text Key: 326076951
• Report Number: 1823260-2023-03356
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: GR
• 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: 12/21/2023

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: 68812401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/21/2023
• 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