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

Catalog Number 09315349190

Device Problems Low Test Results (2458); Material Integrity Problem (2978); Non Reproducible Results (4029)

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

Event Date 10/15/2023

Event Type  malfunction  

Manufacturer Narrative

The e601 module serial number was (b)(6).Qc was acceptable.The investigation is ongoing.

Event Description

The initial reporter questioned the results from 3 samples from 1 patient tested for elecsys troponin t hs stat (troponin t hs stat) on a cobas e 601 module.Sample 1: the initial result was 16 ng/l.The repeat result was 16.8 ng/l.Sample 2 (52 minutes later): the initial result was < 13 ng/l.The "second" result was 118.8 ng/l.It is not clear if the "second" result is from the same sample or a different sample.Clarification has been requested but has not been provided.On (b)(6) 2023, sample 3: the initial result was 932 ng/l.The repeat result was 929.7 ng/l.

Manufacturer Narrative

Calibration was acceptable.The sample coagulation time was "at least" 10 minutes.Based on the sample tubes used by the customer, the minimum recommended clotting time is 30 minutes.Several sample-related alarms were observed on the cumulative alarm trace data.Since this is the cumulative alarm trace, it cannot be identified if one of the alarms was related to the questionable results.Based on the limited information provided, the cause of the event could not be determined.Based on the information available, the investigation determined the event is consistent with sample quality issues.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: 18132481
• MDR Text Key: 328065950
• Report Number: 1823260-2023-03601
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: IS
• 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: 12/20/2023

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: 10/17/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/20/2023
• 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
• Patient Age: 37 YR
• Patient Sex: Male