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

Catalog Number 09315357190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the cobas e 801 analytical unit is (b)(6).Quality controls were within range.The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with elecsys troponin t hs on a cobas e 801 analytical unit.No questionable results were reported outside of the laboratory.The first sample initially resulted in a troponin t value of 9.3 pg/ml and it repeated as 15.0 pg/ml.The sample was decanted into another container, re-centrifuged, and repeated, resulting in a value of 8.9 pg/ml.The second sample initially resulted in a troponin t value of 45.5 pg/ml on (b)(6) 2023 and it repeated as 53.8 pg/ml on (b)(6) 2023.The sample was decanted into another container, re-centrifuged, and repeated, resulting in a value of 55.4 pg/ml on (b)(6) 2023.The third sample initially resulted in a troponin t value of 12.6 pg/ml on (b)(6) 2023 and it repeated as 5.7 pg/ml on (b)(6) 2023.The sample was decanted into another container, re-centrifuged, and repeated, resulting in a value of 4.9 pg/ml on (b)(6) 2023.

Manufacturer Narrative

The customer provided data for three additional patient samples with discrepant troponin t results (samples four, five, and six).Sample four initially resulted in a troponin t value of 33.1 pg/ml on (b)(6) 2023 and it repeated as 19.0 pg/ml.The sample was decanted into another container, re-centrifuged, and repeated, resulting in a value of 16.6 pg/ml.Sample five initially resulted in a troponin t value of 8.7 pg/ml on 17-sep-2023 and it repeated as 6.3 pg/ml.The sample was decanted into another container, re-centrifuged, and repeated, resulting in a value of 4.4 pg/ml.Sample six initially resulted in a troponin t value of 6.5 pg/ml on (b)(6) 2023 and it repeated as 15.0 pg/ml.The sample was decanted into another container, re-centrifuged, and repeated twice, resulting in values of 6.9 pg/ml and 7.1 pg/ml.Qc was within range on the day of sample measurement.A general reagent problem can be excluded, because isolated non-reproducible results do not represent a general malfunction of the assay.The investigation could not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The customer provided data for a seventh patient sample with discrepant troponin t results.This seventh sample initially resulted in a troponin t value of 12.9 pg/ml on 13-oct-2023.The sample repeated with a value of 3.7 pg/ml.The sample was re-centrifuged and repeated, resulting in a value of 3.3 pg/ml.

• Brand Name: ELECSYS TROPONIN T HS
• 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: 17711790
• MDR Text Key: 322973270
• Report Number: 1823260-2023-02928
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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,Followup
• Report Date: 10/24/2023

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: 04/30/2024
• Device Catalogue Number: 09315357190
• Device Lot Number: 68815501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 10/16/2023
• Supplement Dates FDA Received: 09/29/2023; 10/24/2023
• 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