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

Catalog Number	K6421 SMN10445098
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2019-00249 and 2517506-2019-00250 were filed for the same event.Siemens headquarters support center (hsc) completed the investigation of the discordant, falsely elevated cardiac troponin i (ctni) results.Hsc has reviewed the instrument data and the information provided.No product non-conformance was identified with the assay or analyzer.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.File attachments.
Event or Problem Description
Discordant, falsely elevated cardiac troponin i (ctni) results were obtained on patient's samples on a dimension vista 1500 instrument.The results were reported to the physician(s) and questioned.The same samples were processed on the same instrument using the siemens high sensitivity troponin i (tnih) assay after the high ctni results were obtained.The customer indicated the tnih method was being validated.Lower results were obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated ctni results.

• 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: 8722504
• Report Number: 2517506-2019-00248
• Device Sequence Number: 16774909
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K063756
• 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
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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: 09/14/2019
• Device Catalogue Number: K6421 SMN10445098
• Device Lot Number: 18318BC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR