MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OPERATIONS, INC. COAGUCHEK XS PT TEST; TEST, TIME, PROTHROMBIN

Lot Number 32264116

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 08/11/2018

Event Type  malfunction  

Event Description

Some pts experiencing abnormally high inr test results when testing.

• Brand Name: COAGUCHEK XS PT TEST
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8164744
• MDR Text Key: 130500815
• Report Number: MW5082136
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 65702012810
• UDI-Public: 65702-0128-10
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2018

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 Lot Number: 32264116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1