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

Model Number DIMENSION VISTA 1500

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/08/2014

Event Type  malfunction  

Event Description

Discordant chloride (cl) results were obtained on eight patient samples on a dimension vista 1500 instrument.The discordant results were reported to the physician(s).The samples were repeated on an alternate instrument and the corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant cl results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse evaluated the instrument and instrument data and removed, cleaned and reinstalled the integrated multisensor technology (imt) pogo pin.The cse calibrated the imt.The cause of the discordant chloride results was due to a malfunction of the imt pogo pin.The cse successfully ran diluent check and qc.The instrument is performing within specifications.Further evaluation of the device is not required.

• Brand Name: DIMENSION VISTA 1500
• Type of Device: CLINICAL CHEMISTRY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3788023
• MDR Text Key: 15107829
• Report Number: 1226181-2014-00243
• Device Sequence Number: 1
• Product Code: CGZ
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Age: 2 YR
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 05/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2012
• 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