MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 500

Model Number DIMENSION VISTA 500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens healthcare diagnostics inc.(siemens) customer service engineer (cse) was dispatched to the customer site.The cse aligned and cleaned reagent probes 1 and 2 and primed reagent probes 1 and 2 and sample probe 1 (s1).Service methods were performed.During follow-up visits, the cse replaced the aliquot probe and the integrated multi-sensor technology probe and ran a quick check.The cse cleaned all drains and adjusted vacuum, replaced s1 mixer and probe and performed mixer diagnostics test.Quick check and all functional tests were acceptable.The cse calibrated and ran qc for hemoglobin a1c and performed precision testing on patient samples, all of which were acceptable.The cause of the discordant hemoglobin a1c results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

Discordant hemoglobin a1c results were obtained from a dimension vista 500 instrument.The results were reported to the physician(s), who questioned the results.Repeat testing using the same samples was performed on the same dimension vista 500 instrument.Some samples were repeated a second time.The repeat results were reported to the physician(s).

• Brand Name: DIMENSION VISTA 500
• Type of Device: DIMENSION VISTA 500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6513049
• MDR Text Key: 73464662
• Report Number: 2517506-2017-00415
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION VISTA 500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1