MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW DIMENSION VISTA 1500 SYSTEM

Catalog Number SMN10444802

Device Problems Device Issue (2379); Insufficient Information (3190)

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

Event Date 08/02/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens is investigating the issue.

Event Description

An elevated enzymatic creatinine (ecrea) result was obtained on a patient sample on the dimension vista 1500 system.The elevated result followed an acid clean of the probe using acln flex reagent cartridge.It is unknown if the result was reported to the physician.The sample was repeated and a lower result was obtained.It is unknown if there were reports of patient intervention or adverse health consequences due to the elevated ecrea result.

Manufacturer Narrative

The initial mdr 2517506-2016-00370 was filed on october 20, 2016.Additional information (02/28/2017): siemens healthcare diagnostics has confirmed that in isolated cases when ecrea is processed immediately after the weekly automated acid clean routine during probe test, there is the remote potential for an elevation of greater than 15 percent in the ecrea result.While siemens understands that customers routinely run quality control (qc) after system maintenance, it is particularly important to run ecrea qc after the probe test to identify a potential elevated ecrea result.Customers in the united states were sent urgent medical device correction (umdc) vs-17-01.A.Us and customers outside the united states were sent urgent field safety notice (ufsn) vs-17-01.A.Ous in march 2017.The umdc and ufsn are entitled "elevated enzymatic creatinine (ecrea) results following dimension vista acid clean (acln) routine." the umdc and ufsn explain the issue, the risk to health, and the actions to be taken by the customer.

• Brand Name: DIMENSION VISTA 1500 SYSTEM
• Type of Device: DIMENSION VISTA 1500
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW; glasgow business community; 500 gbc drive; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS-BROOKFIELD 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6045537
• MDR Text Key: 58026234
• Report Number: 2517506-2016-00370
• Device Sequence Number: 0
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K051087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Catalogue Number: SMN10444802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2517506-03/09/2017-002-C
• Patient Sequence Number: 1