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

Model Number DIMENSION VISTA® 1500

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

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

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant calcium (ca) result.Ccc reviewed the instrument data and noted several "ac vacuum pump out of range" errors.Quality controls were within range on the date of event.A siemens customer service engineer (cse) was dispatched to the customer site.The cse ran align and fluidics testing, and completed the service mix tests (smt) testing.All smt results were within range.The cause of the discordant, falsely low calcium result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely low calcium (ca) result was obtained on one patient sample on a dimension vista 1500 instrument.The system automatically reran the test, and recovered a higher result.The initial discordant result was not reported to the physician(s).The repeat result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant calcium result.

• 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 # : 1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6522571
• MDR Text Key: 74042155
• Report Number: 2517506-2017-00430
• Device Sequence Number: 0
• Product Code: CJY
• 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
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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: 04/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2013
• 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