MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER,

Model Number DIMENSION VISTA 500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Quality controls were within the acceptable range.The ccc specialist reviewed the process error log and found no errors that occurred at the time the patient sample was affected.The customer stated that no other patient samples were affected.The cause for the discordant, falsely elevated k result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated potassium (k) result was obtained on a patient sample upon repeat testing on a dimension vista 500 instrument.Multiple sample draws were obtained from the patient and were tested on the same dimension vista instrument.The initial result was lower and the consecutive draws resulted higher than the initial results and lower than the result obtained with the first redraw.The result obtained with the fourth sample draw ((b)(6)) was considered correct and was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated k result.

Manufacturer Narrative

Additional information (01-december-2017): a siemens headquarter support center (hsc) specialist reviewed the data which indicates the discordant results are sample specific.

• Brand Name: DIMENSION VISTA 500
• Type of Device: CLINICAL CHEMISTRY ANALYZER,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 7015189
• MDR Text Key: 92638431
• Report Number: 2517506-2017-00807
• 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
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/06/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1