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 07/08/2023

Event Type  malfunction  

Event Description

The initial reporter questioned the results for "several" patient samples tested for elecsys troponin t hs (troponin t hs) on 3 cobas e 801 analytical units.The following are examples of discrepant results for 5 patient samples.On (b)(6) 2023 sample id (b)(6) on analyzer 1: the initial result was 592 pg/ml.The sample was repeated twice with results of 698 pg/ml and 747 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 3: the initial result was 25 pg/ml.The sample was repeated twice with results of 21 pg/ml and 27 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 1: the initial result was 1726 pg/ml.The sample was repeated twice with results of 2570 pg/ml and 2361 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 1: the initial result was 377 pg/ml.The sample was repeated twice with results of 429 pg/ml and 422 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 2: the initial result was 9 pg/ml.The sample was repeated twice with results of 9 pg/ml and 14 pg/ml.

Manufacturer Narrative

E801 analyzer 1 serial number is (b)(6).E801 analyzer 2 serial number is (b)(6).E801 analyzer 3 serial number is (b)(6).Instrument performance testing for analyzer 1 was acceptable.The investigation is ongoing.

Manufacturer Narrative

The customer stated they received discrepant troponin t results for an additional 8 patient samples.Refer to the attachment for all new patient data.

Manufacturer Narrative

The customer complained of discrepant troponin t hs results for additional patient samples: on (b)(6) 2023 sample id (b)(6) on analyzer 1: the initial result was 27 pg/ml.The sample was repeated twice with results of 13 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 1: the initial result was 492 pg/ml.The sample was repeated twice with results of 328 pg/ml and 339 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 3: the initial result was 24 pg/ml.The sample was repeated twice with results of 29 pg/ml and 31 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 2: the initial result was 16 pg/ml.The sample was repeated twice with results of 9 pg/ml and 11 pg/ml.On (b)(6) 2023 sample id (b)(6) on analyzer 1: the initial result was 64 pg/ml.The sample was repeated twice with results of 80 pg/ml and 76 pg/ml.

Manufacturer Narrative

The investigation reviewed sample foam detection images.Sample quality issues were identified (film and particles, bubbles, and clots).Based on the data provided, a general reagent issue can be excluded.The investigation determined the event was due to pre-analytical handling issues.The investigation did not identify a product problem.

• 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: 17643797
• MDR Text Key: 322200142
• Report Number: 1823260-2023-02810
• 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,Followup
• Report Date: 01/26/2024

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: 11/30/2023
• Device Catalogue Number: 09315357190
• Device Lot Number: 64240501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/08/2023; 09/30/2023; 01/25/2024
• Supplement Dates FDA Received: 09/14/2023; 10/23/2023; 01/26/2024
• 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