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

Model Number	TNT G5 STAT
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys troponin t stat assay results on a cobas e 411 analyzer, serial number (b)(4).The initial result was 56.08 pg/ml.The sample was repeated due to the laboratory's policy to repeat critical troponin t stat results.The repeated result was 92.28 pg/ml.The customer noticed the discrepancy and decided to repeat the sample again on a different analyzer.The repeated result, obtained on a different analyzer, was 49.74 pg/ml.This result was deemed correct.The erroneous results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The field service representative replaced the reagent pack using a new lot and performed calibration, which appeared to resolve the issue.Qc, precision, and performance checks passed and the results were within specification.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS TROPONIN T STAT ASSAY
• Common Device Name: 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: 15225922
• Report Number: 1823260-2022-02439
• Device Sequence Number: 5602584
• Product Code: MMI
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: TNT G5 STAT
• Device Catalogue Number: 07398000160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown