MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 1500; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION VISTA 1500

Device Problem Mechanical Problem (1384)

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

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc was granted permission to remotely connect to the instrument.The ccc reviewed the data provided.The customer's quality control (qc) was out of range.A siemens customer service engineer (cse) was dispatched to the customer's site.The cse adjusted the bottom of cuvette corrections for reagent probe 1 and sample probe 1.The cse replaced the sample probe and reagent probe 1 and reagent 1 mixer.The cse performed alignments.The cse ran a quickcheck and qc, resulting within specifications and range.The cause of the discordant, falsely depressed magnesium results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed magnesium results were obtained on patient samples on a dimension vista 1500 instrument.The initial results were reported out to the physician(s).The customer repeated the same sample on an alternate dimension vista instrument, resulting higher.The customer issued corrected reports to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed magnesium results.

• Brand Name: DIMENSION VISTA 1500
• 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 number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6488018
• MDR Text Key: 72678857
• Report Number: 2517506-2017-00387
• Device Sequence Number: 0
• Product Code: JGJ
• 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: 04/12/2017

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: 03/18/2017
• Initial Date FDA Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2013
• 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