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

Catalog Number	K800A SMN 10484429
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens healthcare diagnostics customer care center about the discordant high plasma potassium result.The cause of the discordant high plasma potassium result is unknown.According to customer's clinical specialist, the increase in k result is known as pseudohyperkalemia due to the patient's high white cell count.Per the customer clinical specialist, the 2.8 mmol/l serum result is the most accurate result and was then reported.The customer declined troubleshooting assistance from siemens.Siemens headquarters support center (hsc) concluded their investigation of the incident.No product problem has been identified.The device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant high potassium (k) result was obtained on a plasma sample on the dimension vista 1500 system.The patient plasma result was not reported to the physician.A serum sample from the same draw was run on the same day on the same dimension vista instrument and a lower result was obtained and it was reported.There are no known reports of patient intervention or adverse health consequences due to the discordant high plasma potassium (k) result.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® V-LYTE INTEGRATED MULTISENSOR NA+ K+ CL-
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• MDR Report Key: 6963378
• Report Number: 2517506-2017-00753
• Device Sequence Number: 538188
• Product Code: CEM
• UDI-Device Identifier: 00842768030413
• UDI-Public: 00842768030413
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/19/2017

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: 10/21/2017
• Device Catalogue Number: K800A SMN 10484429
• Device Lot Number: 7DD898
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1