MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T HS STAT; IMMUNOCHEMISTRY ANALYZER

Model Number E411 DISK

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

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

Event Date 09/17/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys troponin t hs stat results for 1 patient sample on a cobas e 411 analyzer (disk system).The initial result was 11.17 pg/ml.The result was reported to the patient's doctor.On (b)(6) 2022 a second primary tube from the same patient was tested and the result was 300 pg/ml.The staff realized the result did not correlate with the patient's clinical history.On (b)(6) 2022 the initial sample was repeated on a different analyzer (cobas e601 module) and the result was 250.3 pg/ml.The same sample was repeated on the e411 analyzer and the result was 11.36 pg/ml.The same sample was tested again and the result was 239.3 pg/ml.The sample was aliquoted and retested and the result was 240.2 pg/ml.The questionable results were reported outside of the laboratory.The reagent lot number is 596372 with an expiration date of march 2023.

Manufacturer Narrative

The calibration on (b)(6) 2022 was within specifications.The qc was within the specified ranges.The calibration and qc data do not point to a general reagent or instrument problem.The patient sample tube was centrifuged at 2840 x g for 10 minutes.The recommended centrifugation conditions were 1800 - 2200 x g for 10 - 15 minutes.The centrifugation speed was higher than recommended by the tube supplier.The alarm trace from (b)(6)-2022 08:41 to (b)(6) 2022 09:15 did not indicate any issues.The investigation did not identify a product problem.The cause of the event could not be determined. .

Manufacturer Narrative

The patient's doctors believed the lower values were more suitable for the patient's clinical picture.The higher values from the e411 and e601 were believed to be incorrect.

• Brand Name: ELECSYS TROPONIN T HS STAT
• Type of Device: IMMUNOCHEMISTRY ANALYZER
• 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: 15608395
• MDR Text Key: 307008290
• Report Number: 1823260-2022-03174
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K201441
• 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
• Report Date: 12/29/2022

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 Model Number: E411 DISK
• Device Catalogue Number: 09315349190
• Device Lot Number: 596372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 10/24/2022; 12/05/2022
• Supplement Dates FDA Received: 11/08/2022; 12/29/2022
• 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