MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center.Quality controls for ctni were acceptable.The ccc specialist reviewed the instrument data and did not find any low ctni values.The values obtained on the dimension vista instrument for samples in question were above analytical measurement range.The values were transmitted to the centralink as no result.The customer notified siemens that the operator manually entered the low ctni results and reported the incorrect results to the physician(s).The cause of the incorrect ctni results being reported to the physician(s) was due to use error.The instrument is performing within manufacturing specifications.No further evaluation of device is required.
Event or Problem Description
The operator of a dimension vista 500 instrument reported incorrect cardiac troponin i (ctni) results on one patient.Different sample draws were obtained from the patient and tested on the same instrument.The results obtained for first, second and fifth sample draws were elevated.The results for third and fourth sample draws obtained on the dimension vista instrument were above analytical measurement range (>40 ng/ml).These results were transmitted to a centalink data management system as no result.The operator inadvertently reported no result from centralink as <0.02 ng/ml to the physician(s).The customer repeated the samples in question on the same instrument, resulting higher.The correct results for the samples in question were reported to the physician(s).There are no reports of patient intervention or adverse health consequence due to the incorrect ctni results being reported to the physician(s).

• Brand Name: DIMENSION VISTA 500
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7689623
• Report Number: 2517506-2018-00421
• Device Sequence Number: 906644
• Product Code: JJE
• UDI-Device Identifier: 00630414593517
• UDI-Public: 00630414593517
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 07/16/2018

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 Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1