MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA® 1500 SYSTEM

Model Number DIMENSION VISTA 1500

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the instrument, the cse replaced reagent probe 3.The cse also replaced horizontal and vertical belts and vertical arm motors for the sample probe 2 arm.The horizontal and vertical motor for the reagent probe 3 arm was also replaced.The cse detailed the cuvette washer, cleaned the sample probe 2 and reagent probe 3 drains, verified proper air knife and vacuum at the drains, cleaned reagent openings around reagent probes 3 and 4, and cleaned the cuvette ring.The photometer, reagent probes 3 and 4, sample probes 1 and 2, and the integrated multi-sensor technology (imt) module were aligned.The barcode reader was adjusted and the sample rack vision system was aligned.Service methods testing and a quick check were run and everything passed.The cause of the discordant, falsely elevated total bilirubin results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Discrepant, falsely elevated total bilirubin results were obtained on four samples on the dimension vista 1500 instrument.The initial results were reported to the physician who questioned the results.The tests were repeated on a different dimension vista 1500 and the results were lower.The repeated results were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated total bilirubin results.

• Brand Name: DIMENSION VISTA® 1500 SYSTEM
• Type of Device: DIMENSION VISTA
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6483523
• MDR Text Key: 72671534
• Report Number: 2517506-2017-00350
• Device Sequence Number: 0
• Product Code: MQM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/11/2017

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 1500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1