MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® MULTI 1 SAMPLE DILUENT

Catalog Number	KD693 SMN 10469971
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics has confirmed that dimension vista® multi 1 sample diluent (multi 1 sdil) lot 7bda81 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.Multi 1 sample diluent (multi 1 sdil) is used for dilutions of samples exceeding the analytical measurement range with the dimension vista® estradiol (e2) flex reagent cartridge.Urgent medical device recall, vc-18-04.A.Us dated march 21, 2018 and urgent field safety notice vc-18-04.A.Ous dated march 2018 were issued to customers who had been shipped dimension vista® multi 1 sample diluent (multi 1 sdil) lot 7bda81 to inform them of the issue.
Event or Problem Description
A falsely elevated estradiol (e2) result was obtained on a cap survey sample on the dimension vista 500 instrument.The result was scored as unacceptable by the cap.There is no indication that patient samples have been affected.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® MULTI 1 SAMPLE DILUENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7376904
• Report Number: 2517506-2018-00196
• Device Sequence Number: 1657593
• Product Code: NDR
• UDI-Device Identifier: 00842768030314
• UDI-Public: 00842768030314
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: 03/01/2018
• Device Catalogue Number: KD693 SMN 10469971
• Device Lot Number: 7BDA81
• 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