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	10/07/2017
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
Discordant elevated estradiol (e2) results were obtained on patient samples on the dimension vista 500 instrument.The results were reported to the physician(s) and questioned.The original samples which had been tested by auto-dilution were repeated by manual dilution and lower results were obtained and reported.There are no known reports of patient intervention or adverse health consequences due to the discordant auto-dilution results.

• 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: 7371141
• Report Number: 2517506-2018-00194
• Device Sequence Number: 11001018
• Product Code: NDR
• UDI-Device Identifier: 00842768030314
• UDI-Public: 00842768030314
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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: Medical Technologist
• 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: 03/26/2018
• 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