MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® CTNI SDIL CTNI SAMPLE DILUENT

Catalog Number	KD692 SMN 10445205
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has confirmed that dimension vista® ctni sample diluent (ctni sdil) lot 7bda34 may have an incomplete slit on the septum in the cap of the vial.A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the dimension vista system, due to a reduced volume of diluent being pipetted from the vial.Ctni sample diluent (ctni sdil) is used for dilutions of samples exceeding the analytical measurement range with the dimension vista® cardiac troponin i (ctni) flex reagent cartridge.Urgent medical device recall, vc-18-04.A.Us dated 21-mar-2018 and urgent field safety notice vc-18-04.A.Ous dated march 2018 were issued to customers who had been shipped dimension vista® ctni sample diluent (ctni sdil) lot 7bda34 to inform them of the issue.
Event or Problem Description
A discordant elevated cardiac troponin i (ctni) result was obtained on a patient sample on the dimension vista 1500 instrument.The result was reported to the physician.The original sample was repeated and a lower result was obtained.A corrected result was reported.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated ctni result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® CTNI SDIL CTNI SAMPLE DILUENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7377869
• Report Number: 2517506-2018-00197
• Device Sequence Number: 1575657
• Product Code: MMI
• UDI-Device Identifier: 00842768015892
• UDI-Public: 00842768015892
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/28/2018

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: 06/01/2018
• Device Catalogue Number: KD692 SMN 10445205
• Device Lot Number: 7BDA34
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2517506-03/22/2018-002-R
• Patient Sequence Number: 1