MAUDE Adverse Event Report: ROCHE COAGUCHEK XS PT TEST STRIP; COAGUCHEK XS STRIPS

Model Number CODE 240

Device Problems Defective Component (2292); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2017

Event Type  malfunction  

Event Description

Coaguchek xs pt test strips for pt inr monitoring have a defective well placement.When placing strip in the coaguchek xs machine (by roche) the blood sample is not able to be placed in the well since it is off center.Dates of use: (b)(6) 2017.Diagnosis or reason for use: pt/inr evaluation.

• Brand Name: COAGUCHEK XS PT TEST STRIP
• Type of Device: COAGUCHEK XS STRIPS
• Manufacturer (Section D): ROCHE
• MDR Report Key: 7145523
• MDR Text Key: 95807733
• Report Number: MW5074221
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/31/2017
• Device Model Number: CODE 240
• Device Lot Number: 16893611
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1