MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; DIMENSION VISTA® CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE

Catalog Number	K6421 SMN 10445098
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2019-00186 was filed for the same event.Siemens headquarters support center (hsc) has reviewed the escalation data and completed the investigation of the discordant, falsely elevated cardiac troponin i (ctni) result.The customer diluted the "below assay range" flagged ctni sample outside of siemens recommendations.Siemens dimension vista operator's guide provides instructions regarding "below assay range" flags.The cause of this event was use error.Reprocessing of the ctni specimen according to the instructions for use showed the patient recovered a cardiac troponin i result of <0.015 ng/ml.No product non-conformance was identified and the customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely elevated cardiac troponin i (ctni) result was obtained on a patient sample on the dimension vista 500 system.The result was reported to the physician(s) and questioned.The same sample was reprocessed on the same instrument and a lower result was obtained and reported.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the discordant ctni result.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8579482
• Report Number: 2517506-2019-00185
• Device Sequence Number: 13905639
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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: 10/19/2019
• Device Catalogue Number: K6421 SMN 10445098
• Device Lot Number: 18353BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1