MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TROPONIN I IMMUNOASSAY; TROPONIN SUBUNIT IMMUNOASSAY METHOD

Catalog Number	05094810160
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys troponin i immunoassay results for one patient tested on a cobas 6000 e 601 module.The e 601 module serial number was (b)(4).Prior to patient testing, the customer reported the troponin qc was acceptable.The patient's initial elecsys troponin result was reported outside the laboratory.The patient's physician questioned the reported troponin result and the customer performed repeat testing.It was reported the patient had a new sample collected "multiple times" over a period of three days and the same results were obtained.The patient's physician reported the elecsys troponin results did not match the patient's clinical picture and the creatinine kinase (ckmb) result.A sample from the patient was sent to a different laboratory and tested on a siemens analyzer.The patient's initial elecsys troponin result was 0.629 ng/ml.The patient's first repeat elecsys troponin result was 0.58 ng/ml.The patient's second repeat elecsys troponin result was 0.615 ng/ml.The patient's new sample had a negative troponin result on a siemens analyzer.The exact result was requested but not provided.The troponin result from the siemens analyzer was determined to be correct.
Additional Manufacturer Narrative
The patient's sample was requested for further investigation, but the sample was not available.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation reviewed the customer's calibration and qc results and the results were within the acceptable ranges.A general reagent issue could be excluded.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.Updated medwatch fields: d4 - lot number, d4- expiration date.

• Brand Name: ELECSYS TROPONIN I IMMUNOASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14675133
• Report Number: 1823260-2022-01706
• Device Sequence Number: 14666412
• Product Code: MMI
• UDI-Device Identifier: 04015630939374
• UDI-Public: 04015630939374
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082699
• 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): 07/11/2022

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 05094810160
• Device Lot Number: 578130
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 07/11/2022
• 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 Age: 29 YR
• Patient Sex: Female