MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN T GEN 5 STAT ASSAY; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Catalog Number	08469865160
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys troponin t gen 5 stat assay (troponin t stat) on a cobas 8000 e 602 module.The initial result at 7:19 p.M.Was 31.50 ng/l with a data flag.At 7:24 p.M.The technician repeated the sample with a manual dilution of 1:10 and the result was 60.00 ng/l with a data flag.The repeat result at 11:59 p.M.Was 26.05 ng/l with a data flag.The initial result of 31.50 ng/l was believed to be correct.
Additional Manufacturer Narrative
The e602 module serial number was (b)(6).H3 other text : na.
Additional Manufacturer Narrative
Qc was acceptable.The technician repeated the sample with a manual dilution of 1:10; the sample was repeated at normal sample volume over 2 hours later with the sample sitting out during that time at room temperature.Product labeling does not recommend dilutions for patient samples and states: "due to possible evaporation effects, samples, calibrators and controls on the analyzers should be analyzed/measured within 2 hours." the investigation determined the event was due to customer handling issues (dilution and sample).

• Brand Name: ELECSYS TROPONIN T GEN 5 STAT ASSAY
• Common Device Name: TROPONIN SUBUNIT IMMUNOASSAY METHOD
• 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: 17375961
• Report Number: 1823260-2023-02406
• Device Sequence Number: 6384244
• Product Code: MMI
• UDI-Device Identifier: 07613336158951
• UDI-Public: 07613336158951
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162895
• 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,Followup
• Report Date (Section B): 08/11/2023

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 08469865160
• Device Lot Number: 68811800
• 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: 07/03/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/11/2023
• 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 Sex: Unknown