MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS PT TEST; TEST, TIME, PROTHROMBIN

Lot Number 32264317

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

Used to check inr.Product recalled.

• Brand Name: COAGUCHEK XS PT TEST
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH ; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8115449
• MDR Text Key: 128946377
• Report Number: MW5081695
• 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: Patient
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/31/2019
• Device Lot Number: 32264317
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1