MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS XPRECIA STRIDE

Catalog Number 10714595

Device Problem Non Reproducible Results (4029)

Patient Problem Pulmonary Embolism (1498)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

This event, escalated to siemens is considered 'off-label use' because the product was sold to a home user and the system is not cleared for sale for patient at-home testing.The instrument has been returned to the distributor.Siemens has requested the instrument and strips to be returned for investigation.When the distributor was asked, if they were aware that this device is not for home use, the distributor stated that in fiscal year 2019, two systems were sold to them.They promoted the system on their website.After it was discovered that the system was sold to a private person, the promotion was removed from the website to prevent this in the future.The cause of this event is unknown.

Event Description

A customer purchased an xprecia stride device on (b)(6) 2019 from an online distributor for home use.The xprecia stride system is not currently approved for home use.The distributor is identified as the initiator of the complaint to siemens.The patient takes coumadin regularly and should always be between 2.5 - 3.5 pt inr.First thing in the morning, the patient spit up blood.The patient already planned on going to the hospital due to spitting blood, but wanted to test his pt inr with xprecia stride anyway.The xprecia pt inr result was higher than the pt inr non-siemens hospital lab device.The patient was later diagnosed with a pulmonary embolism at the hospital.

Manufacturer Narrative

Siemens received the customer's decontaminated xprecia stride (sn (b)(6)) along with pt/inr strips lot # 401635 from the customer.There was no physical damage observed.Good agreement was observed between the customer's analyzer and siemens in-house analyzer (s/n (b)(6)) with retains of the same lot.Both lqc levels were in the specified ranges for pt/inr strips.The customer's analyzer was not statistically different from siemens in-house analyzer.The data files were downloaded and there were several non assay errors found during the customer's usage including: test strip port protective cap missing.Test strip inserted early.Test strip or lqc vial not valid.Apply sample timeout.Early test strip ejection.Test strip port protective cap removed.The quality control results confirm that the customer's analyzer and the pt/inr strips are working as intended.

• Brand Name: XPRECIA STRIDE
• Type of Device: XPRECIA STRIDE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 10242693
• MDR Text Key: 198166216
• Report Number: 3002637618-2020-00030
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K151964
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 10714595
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 08/05/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 40 YR