MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS PRO KIT INTERNATIONAL; PROTHROMBIN TIME MONITOR

Catalog Number 05530199190

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation is health professional.The incident occurred in (b)(6).The meter was requested for investigation.The returned meter was investigation and the touch offset issue was reproducible.The allegation could be confirmed.The display was determined to be defective.

Event Description

The initial reporter complained of a display issue with coaguchek xs pro meter serial number (b)(4).Customer states when they press the display the meter registers the press further down the display than it should.This could lead to a patient information mismatch.No patient information mismatch was reported.

• Brand Name: COAGUCHEK XS PRO KIT INTERNATIONAL
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10763307
• MDR Text Key: 215320091
• Report Number: 1823260-2020-02707
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05530199190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1