MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA; DIMENSION VISTA ® V-LYTE¿ INTEGRATED MULTISENSOR NA+ K+ CL-

Catalog Number	K800A SMN10484429
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00177 was also filed for the same customer inquiry.The customer contacted the siemens customer care center for the discordant, imprecise (k) result on the dimension vista instrument.Siemens headquarters support center (hsc) has completed the investigation of the incident.Hsc evaluated the data provided.The cause of the discrepant imprecise k result cannot be confirmed; however, it is specific to the patient.No product problem has been identified.Qc was within range at the time of testing.The device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, imprecise potassium (k) result was obtained on a patient sample on the dimension vista 500 instrument.The result was reported.There are no reports of patient intervention or adverse health consequences due to the discordant, imprecise potassium result.

• Brand Name: DIMENSION VISTA
• Common Device Name: DIMENSION VISTA ® V-LYTE¿ INTEGRATED MULTISENSOR NA+ K+ CL-
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7339703
• Report Number: 2517506-2018-00175
• Device Sequence Number: 16144833
• Product Code: CEM
• UDI-Device Identifier: 00842768030413
• UDI-Public: 00842768030413
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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 Expiration Date: 05/05/2018
• Device Catalogue Number: K800A SMN10484429
• Device Lot Number: 7LD824
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1