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

Model Number DIMENSION VISTA 1500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 03/11/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a customer care center (ccc) specialist.The ccc reviewed the data provided.The ccc found the customer's quality control (qc) was in at the time of the event.Siemens is investigating the event.

Event Description

A discordant, falsely depressed urine enzymatic creatinine result was obtained on a patient sample on a dimension vista 1500 instrument.The initial result was not reported out to the physician(s).The customer did not spin the sample and repeated the same sample on the same dimension vista 1500 instrument, resulting higher.The customer spun the sample and tested the sample on an alternate dimension vista instrument, resulting higher.The customer repeated the same sample on the alternate dimension vista instrument, resulting higher than the initial result.The first result from the alternate instrument was reported out.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed urine enzymatic creatinine result.

Manufacturer Narrative

The initial mdr 2517506-2017-00355 was filed on april 5, 2017.Additional information (05/05/2017): the siemens headquarters support center (hsc) reviewed the event.Hsc stated there is no indication of reagent delivery or foaming issues found based on the data supplied.There were no other issues noted or found.The cause of the discordant, falsely depressed urine enzymatic creatinine result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA 1500
• 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 number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6461845
• MDR Text Key: 71835725
• Report Number: 2517506-2017-00355
• Device Sequence Number: 0
• Product Code: JFY
• 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: 06/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• 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: 05/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2008
• 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