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 01/23/2017

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 allowed ccc specialist a remote connection to the system.The ccc specialist reviewed the instrument data and observed variable b errors, which indicated sample probe mix issue.A siemens customer service engineer (cse) was dispatched to the customer site.The cse ran service methods and discovered that the sample probe 1 (s1) undermix was out of specifications.The cse pulled the arm and swapped with sample 3 (s3) mixer.The cse aligned the arm and ran a quick check.The cse moved the methods off server 3.The cse ran qc and performed calibrations.The cse revisited the customer site the next day and replaced s1 mixer, s1 probe and aligned s1 & sample probe 2 (s2).The cse ran a quick check, which passed.The cse ran qc, which were within range.The cse performed calibrations, which passed.The cause of falsely depressed glu result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely depressed glucose (glu) result was obtained on a patient sample on a dimension vista 1500 instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument, resulting higher.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed glu result.

• 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: 6335427
• MDR Text Key: 67664712
• Report Number: 2517506-2017-00173
• Device Sequence Number: 0
• Product Code: CFR
• 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: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• 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: 01/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2011
• 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