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

Catalog Number	K6421 SMN 10445098
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens headquarters support center (hsc) completed the investigation of the discordant, falsely depressed cardiac troponin i (ctni) results.Hsc has reviewed the instrument data and the information provided.The instrument data indicates that flex reagent cartridge sequence number 9411 of the reagent lot 19031aa had insufficient volume of biotinylated antibody reagent in well 2.The insufficient volume caused a depression of the loci reaction resulting in the low values generated for sample ids (b)(6).Hsc indicated no issues in volume of the biotinylated antibody reagent before and after the reagent cartridge flexes were filled.Hsc performed a manufacturing batch history review on lot 19031aa and there was no indication of an issue during filling and packaging.No other flex reagent cartridges for lot 19031aa were affected when processed on the alternate dimension vista analyzers.This is an isolated event and the cause of the low well volume is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant, falsely depressed cardiac troponin i (ctni) results were obtained on two patient samples on the dimension vista 1500 instrument.The discordant results were reported to the physician(s) and questioned.The same samples were reprocessed on two alternate vista instruments and higher results were obtained and corrected.There are no known reports of patient intervention or adverse health consequences due to the discordant ctni results.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® CTNI CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 8662980
• Report Number: 2517506-2019-00226
• Device Sequence Number: 2087048
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/03/2019

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: 12/01/2019
• Device Catalogue Number: K6421 SMN 10445098
• Device Lot Number: 19031AA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1