MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant sodium results.The ccc checked the system remotely.Quality control (qc) was within range.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed power flush.The cse replaced all consumables and imt tubing.The cse ran dilution check, which passed.The cse ran qc, which was acceptable.The cause of the discordant sodium results is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

Discordant sodium results were obtained on patient samples on a dimension vista 1500 instrument.The discordant results were reported to the physician(s), who questioned them.The samples were repeated on an alternate instrument.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant sodium results.

Manufacturer Narrative

The initial mdr 2517506-2017-00786 was filed on (b)(6) 2017.Additional information (10/31/2017): a siemens headquarter support center (hsc) specialist reviewed the instrument data, which indicated a fluid flow problem.Process errors and service actions indicated that there was a maintenance need at the time of discrepant results.Average sodium standard deviation above 0.01 mv is an indicator of a poorly grounded integrated multisensor technology (imt) module, which results in imt data unstable errors.Poor sample quality and the presence of gel, fibrin, and cellular material in the sample(s), causing an obstruction, can be a contributing factor to discordant results.The cause of the discordant results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6969284
• MDR Text Key: 90755254
• Report Number: 2517506-2017-00786
• Device Sequence Number: 0
• Product Code: JGS
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2016
• 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