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

Catalog Number 04625374160

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2018

Event Type  malfunction  

Event Description

Received a / some bad lots of roche diagnostics alere coaguchek inr test strips.

• Brand Name: COAGUCHEK XS PT INR TEST STRIPS
• Type of Device: TEST TIME PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS INC.
• MDR Report Key: 8079918
• MDR Text Key: 127855264
• Report Number: MW5081417
• 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: Patient
• Type of Report: Initial
• Report Date: 11/15/2018

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 Expiration Date: 10/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 31504821
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 69