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

Lot Number 35350321

Device Problems Failure to Read Input Signal (1581); Defective Device (2588)

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

Event Date 11/17/2018

Event Type  malfunction  

Event Description

Received test strips lot 35350321 suppose to be replacement for recalled strips.Went through 6 strips blood not registering machine.Have been using this system for a year, never had this problem.I think the new strips are defective also.I've been using the bad strips for a while now having my warfarin moved and down because of drastic changes in readings.Machine chace (b)(4).

• Brand Name: COAGUCHEK XS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8094608
• MDR Text Key: 128276305
• Report Number: MW5081518
• 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: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 35350321
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 113