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

Model Number	10471067
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has investigated the event of discordant low results with high sensitivity troponin i (tnih) on the dimension vista system with lot 20008bb.Siemens has observed a negative bias across the analytical measurement range of the tnih assay.Siemens tested lot 20008bb and a negative bias was confirmed.Siemens internal testing observed an average bias for patient samples for lot 20008bb of -20%.Urgent medical device correction, vc-20-03.A.Us dated july 24, 2020 and urgent field safety notice vc-20-03.A.Ous dated july 2020 is addressed to customers who had been shipped dimension vista® high sensitivity troponin i (tnih) lots 20008bb, 20035bc and 20135bb.Customer were instructed that they should recalibrate the tnih lots and to enter lot specific correlation factors c0 and c1 in the method configuration screen per flex reagent lot as listed in the communications.After applying correlation factors to the specified lot, product claims listed in the instructions for use are met.Siemens is working to restore assay performance, and until such time, subsequent lots may contain an alert card in the carton containing lot specific correlation factors.
Event or Problem Description
Discordant low results were obtained during a new lot comparison study for high sensitivity troponin i (tnih) on the dimension vista 1500 system.Lower results were obtained after calibration of new lot 20008bb relative to the previous lot in a correlation study.The patient comparison study results on patient correlation samples were not reported to physicians.There are no reports of patient intervention or adverse health consequences due to the discordant low high sensitivity troponin i (tnih) patient correlation results.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA® TNIH HIGH SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10379685
• Report Number: 2517506-2020-00217
• Device Sequence Number: 14245015
• Product Code: MMI
• UDI-Device Identifier: 00842768037719
• UDI-Public: 00842768037719
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K182225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/07/2020

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: 11/03/2020
• Device Model Number: 10471067
• Device Catalogue Number: K6427 SMN 10471067
• Device Lot Number: 20008BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 08/07/2020
• 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: 2517506-07/30/2020-001-C
• Patient Sequence Number: 1