MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; CLINICAL CHEMISTRY ANALYZER,

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 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and stated that their quality controls (qc) were within acceptable range on the day the event occurred.The customer determined the issue was with the original sample from the patient and the customer was satisfied with the instrument performance.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely elevated creatinine (cre2) result was obtained on a patient sample on a dimension vista 500 instrument.The discordant result was reported to a nurse practitioner(s) who questioned it.The patient was redrawn and the sample was tested on the same dimension vista instrument, resulting lower and matching the patient's historical results.The original sample was then spun and repeated on two dimension vista instruments, matching the original high result.The redraw result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low cre2 result.

Manufacturer Narrative

The initial mdr 2517506-2017-00380 was filed on april 12, 2017.Additional information (05/22/2017): a siemens headquarters support center (hsc) specialist evaluated the data related to the event and could not determine the cause of the discordant, ecre2 result.Corrections (05/26/2017): reworded to reflect falsely elevated ecre2, sample id were added, additional text was added, correct serial number and udi number were added and correct instrument manufacturing date was added.

Event Description

There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated cre2 result.

• Brand Name: DIMENSION VISTA 500
• Type of Device: CLINICAL CHEMISTRY ANALYZER,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6487839
• MDR Text Key: 72673810
• Report Number: 2517506-2017-00380
• Device Sequence Number: 0
• Product Code: CGX
• 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,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• 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
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2010
• 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