MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® CARDIAC TROPONIN I CALIBRATOR

Catalog Number	KC678 SMN 10445197
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) regarding depressed cardiac troponin i (ctni) results obtained on the dimension vista 1500 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the event.Hsc has reviewed the information provided and instrument data logs.The event was a low bias in cardiac troponin i (ctni) results after a new calibration of the dimension vista cardiac troponin i reagent which occurred on the day of the event, (b)(6) 2019.The instrument data reviewed showed an atypical high signal recovery with the level a cardiac troponin i calibrator which created a bias in results at the low end of the assay range.No other reports similar to this event with the same calibrator lot have been received by siemens.The cardiac troponin i calibrator was completely consumed by the customer and not available for return to siemens for further investigation.The customer is operational after recalibration of the cardiac troponin i assay with an alternate lot of cardiac troponin i calibrator.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
Discordant depressed cardiac troponin i (ctni) results were obtained on patient samples on the dimension vista 1500 system after calibration with the cardiac troponin calibrator (ctni cal).The low results were reported to the physician(s).After recalibration, the samples were reprocessed on the same system and higher results were obtained.Corrected reports were issued.There are no known reports of treatment changes or adverse health consequences due to the discordant depressed ctni results.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® CARDIAC TROPONIN I CALIBRATOR
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 8641504
• Report Number: 2517506-2019-00218
• Device Sequence Number: 10833996
• Product Code: JIT
• UDI-Device Identifier: 00842768016738
• UDI-Public: 00842768016738
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 05/24/2019

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: 01/01/2020
• Device Catalogue Number: KC678 SMN 10445197
• Device Lot Number: 9AD053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1