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

Catalog Number K800A SMN 10484429

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Mdr 2517506-2018-00556 was also filed for the same event.The customer contacted the siemens customer care center (ccc) and reported that a depressed patient potassium result obtained on the dimension vista system was questioned by the physician.Siemens is investigating the event.

Event Description

A discordant depressed potassium (k) result was obtained on a patient serum sample on the dimension vista 500 system.This result was reported to the physician who questioned the result.A new sample was drawn later the same day and a higher result was obtained in agreement with earlier results at an alternate facility.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed potassium result.

Manufacturer Narrative

Original mdr 2517506-2018-00555 was filed (b)(6) 2018.Mdr 2517506-2018-00556 was filed for the same event.Additional information (b)(6) 2018) siemens headquarters support center (hsc) has completed the investigation of the instrument data logs and the information provided by the customer.The cause of the discordant potassium patient results cannot be confirmed but is specific to this patient.Quality control was in range at the time of discrepant results, and no other patient's results were impacted.The cause of the discordant potassium results is unknown.No nonconformance with the instrument or reagent was identified.No further evaluation of the device is required.Section has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION VISTA
• Type of Device: 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: 7920014
• MDR Text Key: 124569180
• Report Number: 2517506-2018-00555
• Device Sequence Number: 1
• Product Code: CEM
• UDI-Device Identifier: 00842768030413
• UDI-Public: 00842768030413
• Combination Product (y/n): N
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2018
• Device Catalogue Number: K800A SMN 10484429
• Device Lot Number: 8DD845
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 09/28/2018
• Supplement Dates Manufacturer Received: 10/04/2018
• Supplement Dates FDA Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1