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

Catalog Number 08469814190

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

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

The event was consistent with a preanalytic issue.The customer was not following the tube manufacturer's recommendation for centrifugation conditions and clotting time.The calibration and qc data were acceptable.The data did not indicate a reagent issue.The analyzer alarm trace contained multiple alarms related to issues with sample pipetting.The investigation is ongoing.

Event Description

There was an allegation of questionable troponin t hs stat elecsys results from cobas 6000 e601 module serial number (b)(4).The issue occurred with multiple samples from the same patient.After the third sample from the patient was completed on (b)(6) 2023 with a result of 28 pg/ml, the customer received information that the patient had suffered from a heart attack and this third result was considered correct.The customer then repeat the first and second samples drawn from the patient and the results were higher than initially obtained.On (b)(6) 2023, sample 1 initial result had been 5 pg/ml and was reported outside of the laboratory.On (b)(6) 2023, the sample was repeated on another cobas 6000 with a result of 12.11 pg/ml.On (b)(6) 2023, sample 2 initial result had been 3.49 pg/ml and was reported outside of the laboratory.The sample was repeated on another cobas 6000 and the results were 13.54 pg/ml and 15.59 pg/ml.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16612866
• MDR Text Key: 312301356
• Report Number: 1823260-2023-00968
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• 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: 03/31/2023
• Device Catalogue Number: 08469814190
• Device Lot Number: 596381
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• 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