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

Model Number	TNT G5 STAT
Medical Device Problem Codes	No Apparent Adverse Event (3189); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) inspected the module and performed mechanical checks to ensure the module's proper functions.The results were successful.The customer performed qc and a precision test with successful results.
Event or Problem Description
The initial reporter received questionable elecsys troponin t stat assay (troponin t stat) results from three samples from the same patient tested on the customer's cobas 6000 e 601 module with serial number (b)(4) (module a), the customer's alternate e 601 with serial number 28a0-16 (module b) and another laboratory's e 601 with serial number (b)(4) (module c).An aliquot initial sample collected at 1:38 am was received by the reporter from another laboratory.The initial result of this aliquot initial sample at 5:00 am from module a was 22.17 ng/l.This result was reported outside of the laboratory.A second sample from the patient collected at 2:57 am was received by the other laboratory.The result of the second sample from module c was <6 ng/l.The doctor informed the other laboratory that there was a drastic difference between the results and requested a rerun.The aliquot initial sample retained in the other laboratory was then rerun.The repeat result of this aliquot initial sample from module c was <6 ng/l with a data flag.The reporter reran the aliquot initial sample they received in module a and module b.The first repeat result of this aliquot initial sample at 8:00 am from module a was 13.56 ng/l.The second repeat result of this aliquot initial sample at 8:00 am from module b was 9.17 ng/l.A third sample was collected from the patient at 4:50 am.The result of the third sample was 7 ng/l.No result was deemed correct.  the reagent lot number used at the customer's alternate e 601 (module b) and the other laboratory's e 601 (module c) and their expiration dates were requested but not provided.
Additional Manufacturer Narrative
For the customer's module a: the calibration performed on (b)(6) 2022 was within specifications.The customer's qc recovery had results outside the - 2 sd (standard deviation) range.The alarm trace did not indicate any issues.After service, no further issues were reported by the customer.  the investigation determined the service actions resolved the issue.  the cause of the event could not be determined.

• 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: 15982649
• Report Number: 1823260-2022-04020
• Device Sequence Number: 6922906
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: TNT G5 STAT
• Device Catalogue Number: 07398000160
• Device Lot Number: 630063, ASKU, 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: 11/18/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 01/27/2023
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 103 KG