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

Catalog Number 07398000160

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

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

Event Date 10/08/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys troponin t stat assay on a cobas e411 rack.The first sample initially resulted in a troponin t value of less than 6 ng/l.The patient had a previous sample that resulted in a troponin t value of 15 ng/l, so the complained sample was repeated.The repeat result of the complained sample was 12 ng/l.The second sample initially resulted in a troponin t value of less than 6 ng/l.The patient had a subsequent sample that resulted in a troponin t value of 55 ng/l, so the complained sample was repeated.The repeat result of the complained sample was 56 ng/l.

Manufacturer Narrative

The serial number of the e411 analyzer is (b)(6).The investigation is ongoing.

Manufacturer Narrative

The last calibration performed on 03-oct-2023 was ok and there were no alarms.Quality controls recovered within range.There was no indication of a reagent performance issue.The field service engineer checked the analyzer and performed probe adjustments.The reagent wheel grounding and resistance were checked.Performance testing was run and recovered within specifications.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• Type of Device: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18031211
• MDR Text Key: 326867931
• Report Number: 1823260-2023-03464
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K961481
• 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
• Report Date: 12/01/2023
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 07398000160
• Device Lot Number: 672042
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/30/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/01/2023
• 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: 77 YR