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 01/15/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).The quality controls (qc) were within range on the day of the event.The customer care center (ccc) performed service method tests (smt) and found that the reagent probe 2 (r2), sample probe 1 (s1) and mixer were out of range.A siemens customer service engineer (cse) was dispatched to the customer site.The cse switched the server 1 and server 3 mixers and moved all tests from server 3.The cse replaced s1 and aligned other probes.The cse primed the system and ran a quick check, which passed.The cse ran qc, which were within range.The cause of discordant, falsely depressed mg results on patient samples is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely depressed magnesium (mg) results were obtained on patient samples on a dimension vista 1500 instrument.The discordant results were not reported to the physician(s).The samples were repeated on the same instrument, resulting higher.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed mg 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 19702
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6315685
• MDR Text Key: 67297713
• Report Number: 2517506-2017-00151
• 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: 02/09/2017

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: 01/15/2017
• Initial Date FDA Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2014
• 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