MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA®; DIMENSION VISTA® SYSTEM 500

Model Number DIMENSION VISTA 500 DOMESTIC

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

The customer called into the siemens customer care center reporting falsely depressed serum results.The issue was identified as a user error.On (b)(6) 2016 the customer had incorrectly changed the serum potassium method comparison coefficients instead of the urine method comparison coefficients on the dimension vista® 500 intelligent lab system, after receiving customer notification vc-17-01.A.Us, dated december 19, 2016.The customer notification instructed customers that siemens healthcare diagnostics has confirmed a low bias for dimension vista v-lyte integrated multisensor urine potassium (k) when compared to the dimension quiklyte® integrated multisensor, which is the predicate device used in the method comparison section of the v-lyte instructions for use (ifu).This bias affects patient results and qc and could result in failures in accuracy-based proficiency testing programs.The customer notification instructed the customer to change the method comparison coefficients for urine potassium only to compensate for this bias, and new method comparison coefficients were provided.The instructions stated that the correlation factors should be applied to the urine sample type only and emphasized that serum potassium results are not affected by this issue as there are separate parameters for serum potassium.The customer notification provided illustrations of the proper installation of the urine potassium coefficients within the method configuration screen.In this instance, the customer entered the c0 and c1 coefficient values provided into the serum potassium method configuration rather than for the urine potassium method configuration.This error caused the falsely depressed results obtained for serum samples.In this instance, patient samples were run prior to running qc which detected the error.The issue was resolved by the customer correcting the coefficient values for serum and properly entering the urine coefficients.The correction was verified by qc.The instrument is performing within specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed serum potassium (k) results were obtained on qc and patient samples on the dimension vista 500 system.The discordant results were reported to the physician(s).The same samples were repeated on an alternate dimension vista instrument after an error in the entry of method comparision correlation factors was detected.Higher results were obtained on the alternate instrument which had not had method comparison correlation factors entered.The account stated nine patients were treated for low potassium.Information on the nature of the treatment was not provided.There are no reports of adverse health consequences due to the discordant, falsely depressed serum potassium results or treatment.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® SYSTEM 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; registration number 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: james morgera ; glasgow business community; 500 gbc drive po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 6265557
• MDR Text Key: 65356810
• Report Number: 2517506-2017-00059
• Device Sequence Number: 0
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 500 DOMESTIC
• Device Catalogue Number: SMN 10284473
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2016
• Initial Date FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1