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

Model Number DIMENSION VISTA 1500

Device Problems False Device Output (1226); Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

A discordant, falsely low vancomycin result was obtained on one patient sample on a dimension vista 1500 instrument.The discordant result was reported to the physician(s), who questioned it.The sample was repeated on the same instrument and on another dimension vista 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 low vancomycin result.

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).Ccc evaluated the instrument data and determined that quality controls were within range at the time of event.The cause of the discordant, falsely low vancomycin result is unknown, as the sample resulted as expected upon repeat testing on the same instrument.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 4186180
• MDR Text Key: 18796151
• Report Number: 1226181-2014-00519
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2014
• Is this an Adverse Event Report?: No
• 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: 09/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2010
• 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