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

Catalog Number	K6421 SMN10445098
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) and reported a depressed cardiac troponin i (ctni) patient result was obtained on a dimension vista 500 instrument.Siemens is investigating the event.
Event or Problem Description
A discordant, falsely depressed cardiac troponin i (ctni) result was obtained on a patient sample on a dimension vista 500 instrument.The result was reported to the physician(s) and questioned.The same sample was also processed after dilution and a higher result was obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant ctni result.
Additional Manufacturer Narrative
Mdr 2517506-2019-00460 was filed on 11-dec-2019.Additional information (03-jan-2020): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant cardiac troponin i (ctni) results.Hsc evaluated the information provided and the instrument data files.No product malfunction was identified with the dimension vista 500 system or the ctni reagent.The customer stated that the sample was sent out for testing on an alternate technology and resulted as <0.02 ng/ml.The customer considers the <0.02 ng/ml result to be correct.The sample in question yielding unexpected results on the dimension vista 500 system when diluted is suggestive of an interferent specific to this patient sample.The dimension vista ctni instruction for use (ifu) states: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results." no additional similar discrepant results from other patients were reported by this customer.The cause is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• 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: 9453942
• Report Number: 2517506-2019-00460
• Device Sequence Number: 3078476
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 01/15/2020

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: 06/06/2019
• Device Catalogue Number: K6421 SMN10445098
• Device Lot Number: 19157BB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2019
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1