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	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens headquarters support center (hsc) has reviewed the customer information provided and the instrument data.No product non-conformance was identified.The data indicated that only samples processed with ctni reagent lot 19056bb on dimension vista instrument dv310846 were affected.The instrument data showed that the instrument loci reader was replaced on (b)(6) 2019 at approximately 11 am.After the loci reader replacement, quality control (qc) and calibrations were not performed on ctni reagent lot 19056bb.The cause of this event was due to the changes in recovery for ctni reagent lot 19056bb after the loci reader replacement.The event was resolved with the recalibration of ctni reagent lot 19056bb.Post calibration, quality control (qc) returned to within customer ranges and ctni reagent lot 19056bb is operational.The device is performing according to specifications.No further evaluation of the device is necessary.
Event or Problem Description
Discordant elevated cardiac troponin i (ctni) results were obtained on quality control (qc) and patient's samples on a dimension vista 1500 instrument.The patient results were reported to the physician(s).The same patient samples were reprocessed on an alternate dimension vista.Lower results were obtained.Corrected reports were issued.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: 8771181
• Report Number: 2517506-2019-00273
• Device Sequence Number: 16638847
• Product Code: MMI
• UDI-Device Identifier: 00842768015151
• UDI-Public: 00842768015151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/09/2019

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: 12/26/2019
• Device Catalogue Number: K6421 SMN 10445098
• Device Lot Number: 19056BB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1