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

Catalog Number 09315357190

Device Problems High Test Results (2457); Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 10/23/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The field service engineer (fse) found that the pro-cell syringe and tubing was discolored and decontaminated it, bleached the wash cups, and ran an instrument check successfully.The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys troponin t hs assay results for 3 patient samples on a cobas e 801 analytical unit.On (b)(6) 2023, sample 1 had an initial troponin result of 4.48 ng/l with flag.The customer was prompted to repeat the sample as the initial result was accompanied by a data flag.The sample was repeated four times and the results were 10.1 ng/l, 15.5 ng/l, 11.1 ng/l, and 9.94 ng/l.On (b)(6) 2023, sample 2 had an initial troponin result of <3 ng/l.The customer was prompted to repeat the sample as the initial result below the measuring range of the assay.The sample was repeated twice and the results were 17 ng/l and 22 ng/l.On (b)(6) 2023, sample 3 had an initial troponin result of 14.7 ng/l.The repeat result was 127 ng/l.

Manufacturer Narrative

No product problem was identified.The root cause of the event was found to be consistent with pre-analytical sample handling issues.

• Brand Name: ELECSYS TROPONIN T HS
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18162202
• MDR Text Key: 328427014
• Report Number: 1823260-2023-03653
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): Y
• Reporter Country Code: EI
• PMA/PMN Number: K201441NA
• 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: 02/05/2024

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: 04/30/2024
• Device Catalogue Number: 09315357190
• Device Lot Number: 68815500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 02/05/2024
• 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