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 02/06/2017

Event Type  malfunction  

Manufacturer Narrative

The customer called into the siemens customer care center reporting falsely depressed serum potassium results.The issue was identified as a user error.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 issue was detected by qc and patient serum k samples were run while the incorrect method comparison coefficients were entered.The customer stated that they did not recall the date the incorrect method comparison coefficients were entered but the qc excursion was noted on february 6, 2017.The method comparison coefficients were corrected on february 7, 2017 and qc returned to within laboratory ranges.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.The issue was resolved by the customer correcting the coefficient values for serum and properly entering the urine coefficients.A customer notification follow up information vc-17-01.B.Us dated january 26, 2017 was sent to customers to reinforce the instructions of the original customer notification.It stated: "siemens has learned that there have been reports of customers inadvertently entering the method comparison coefficients indicated for urine potassium into the serum or plasma tab.Siemens healthcare diagnostics is issuing this customer notification with enhanced instructions for updating and verifying the urine potassium method comparison coefficients.Please follow the enhanced instructions below even if you have already updated the urine potassium coefficients provided in the previous customer notification, vc-17-01.A.Us.The serum and plasma potassium comparison coefficients should not be changed on your system." siemens has confirmed that the customer was on the original mailing lists for the customer notification vc-17-01.A.Us as well as for the follow up information communication vc-17-01-b.Us.Receipt of the original mailing was confirmed to siemens on the day following the mailing, december 20, 2016.Receipt of the follow-up mailing was confirmed to siemens on january 27, 2017.The customer returned the fax back form for the follow-up mailing on february 9, 2017.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.Patient results were reported to physicians.Once the low qc was detected, an error in the entry of method comparison correlation factors was detected.Corrected results were reported.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed serum potassium results.

• 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: 6385243
• MDR Text Key: 69291480
• Report Number: 2517506-2017-00170
• 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: 03/07/2017

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: 02/07/2017
• Initial Date FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2014
• 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