MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Model Number E801

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

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) checked pump pressures and all probes.Measuring cell (mc) preparations were performed.No issues were identified.All mechanisms were working properly.The customer ran a patient comparison for troponin t and ran qc with no issues.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for elecsys troponin t gen 5 (troponin t) on a cobas e 801 module.The patient was originally tested for troponin t with a result of approximately 24 ng/l.A 2nd sample was obtained and the initial result was 6.97 ng/l.This result was reported outside of the laboratory where it was questioned by the physician.The 2nd sample was repeated with a result of 23.2 ng/l.This result was believed to be correct.The troponin t reagent lot number was 6424120.The expiration date was not provided.

Manufacturer Narrative

The troponin t reagent lot number expiration date was 30-nov-2023.Calibration was last performed on 27-apr-2023 with acceptable results.No qc data was provided; the customer stated qc was acceptable.No issues were identified during a review of the alarm trace data.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The suspect medical device was updated.Relevant fields of sections d and g were updated.The e801 module serial number was (b)(6).

• Brand Name: ELECSYS TROPONIN T GEN 5
• Type of Device: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• 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: 17064203
• MDR Text Key: 317230141
• Report Number: 1823260-2023-01822
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 07613336158982
• UDI-Public: 07613336158982
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2023

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: 11/30/2023
• Device Model Number: E801
• Device Catalogue Number: 08469890160
• Device Lot Number: 6424120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 06/22/2023
• Supplement Dates FDA Received: 06/23/2023; 07/17/2023
• 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: 85 YR
• Patient Sex: Female