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

Model Number DIMENSION VISTA 1500

Device Problem High Test Results (2457)

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

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) specialist was dispatched to the customer site.After evaluating the instrument, the cse found that the integrated multi-sensor technology (imt) probe was bent and he replaced it.The cse performed precision testing and ran quality controls, which were acceptable.The cause of the discordant, falsely elevated hba1c results on multiple patient samples was due to a malfunction of the imt probe.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely elevated hemoglobin a1c (hba1c) results were obtained on multiple patient samples on a dimension vista 1500 instrument.The discordant results were reported to the physician(s), who questioned them.The patients with sample ids (b)(6) were treated with insulin due to the discordant hba1c results.The samples were repeated on an alternate dimension vista 1500 instrument, resulting lower.The corrected results from the alternate dimension vista instrument were reported to the physician(s).There are no reports of adverse health consequences due to the discordant, falsely elevated hba1c results.

• 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: michael metz ; 511 benedict ave; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 5329870
• MDR Text Key: 35033059
• Report Number: 1226181-2015-00719
• Device Sequence Number: 0
• Product Code: LCP
• 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: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• 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: 12/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2011
• 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