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

Model Number E411 DISK

Device Problem Low Test Results (2458)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t gen.5 stat assay on a cobas e 411 immunoassay analyzer.The sample initially resulted in a troponin t value of 18 ng/ml and this value was reported outside of the laboratory.The physician rejected the result as it did not match the patient's history.The sample was repeated, resulting in a value of 501 ng/ml.The repeat value was deemed correct.The troponin t reagent lot was 688118.The reagent expiration date was requested, but not provided.

Manufacturer Narrative

The last calibration performed on 26-feb-2023 was ok and there were no alarms.Quality controls were within range.Upon review of the alarm trace, no relevant alarms were observed.The field service engineer could not determine a cause.The system was inspected and testing was completed without issue.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• 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: 16567018
• MDR Text Key: 311579129
• Report Number: 1823260-2023-00871
• Device Sequence Number: 1
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162895
• 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: 04/10/2023

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: 03/31/2024
• Device Model Number: E411 DISK
• Device Catalogue Number: 08469865160
• Device Lot Number: 688118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/10/2023
• 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
• Treatment: ASPIRIN; DABAPENTIN; LOZARTAN TABLET; NACL INTRAVENOUS FLUID; NITROGLYCERIN; ROSUVASTATIN; TEMPSOLOCIN; TIACAGLORE
• Patient Age: 61 YR
• Patient Sex: Male