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

Catalog Number 09315357190

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

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys troponin t hs assay on a cobas e 801 analytical unit, serial number (b)(6).The sample was initially tested three times, resulting in troponin t hs values of 177 pg/ml, 269 pg/ml and 162 pg/ml.The sample was stored overnight at 4°c and repeated five times the next day on two different instrument lines.The sample resulted in troponin t hs values of 289 pg/ml, 293 pg/ml, 289 pg/ml, 292 pg/ml and 290 pg/ml on the initial instrument line.The sample resulted in troponin t hs value of 286 pg/ml, 282 pg/ml, 284 pg/ml, 286 pg/ml and 282 pg/ml on a second instrument line.

Manufacturer Narrative

H3 other text : na.

Manufacturer Narrative

Calibration results were acceptable.The sample centrifugation time may have been shorter and the speed may have been higher than recommended by the tube manufacturer.A re-analysis of release data and the reproducibility of release testing with reagents over the shelf life showed no evident quality issues.The performance was according to specification and release criteria, with comparable performance to previous reagent lots.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17228180
• MDR Text Key: 318964097
• Report Number: 1823260-2023-02127
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/13/2023

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: 11/30/2023
• Device Catalogue Number: 09315357190
• Device Lot Number: 64240501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 10/19/2023
• Supplement Dates FDA Received: 11/13/2023
• 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