MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS XPRECIA STRIDE JAPAN

Catalog Number 11065084

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 05/08/2018

Event Type  malfunction  

Manufacturer Narrative

As per the user manual: "warning! clinical studies have shown that xprecia stride pt/inr results from a venous sample were falsely low when compared to a capillary sample from the same patient.Testing of venous samples should not be performed on xprecia stride".As per the user manual: "only use fresh whole blood from a capillary (finger-stick) source with test strips".The customer stated that their instrument was replaced with a new one on (b)(6) 2018 and the qcs were in the reference range and is operational.The cause for this event is unknown.

Event Description

The customer reported that a patient is being seen at an orthopedic clinic and the clinic increased the dose of eperisone from 1 tablet to 3 tablets.On the same day, the patient took eperisone and became sick at night.Then the patient took micinazole nitrate and stopped warfarin potassium.Also, bleeding was observed.The next morning at 9:00 am, the patient went to the orthopedic clinic and subcutaneous bleeding was still observed at that time.Initial inr was measured at 10:30 am that morning.The customer reported discrepant xprecia stride pt/inr results when they were compared to results from a hospital lab and another external lab.The pt/inr test methods used by the hospital lab and the external lab are unknown.

• Brand Name: XPRECIA STRIDE JAPAN
• Type of Device: XPRECIA STRIDE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): PLEXUS MANUFACTURING SDN. BHD.; plot 87 lebuhraya kampung jawa; bayan lepas pulau pinang, 11900 ; MY 11900
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 7544478
• MDR Text Key: 109368326
• Report Number: 3002637618-2018-00064
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11065084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: No
• 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