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

Lot Number 28631924

Device Problem Nonstandard Device (1420)

Patient Problems Fall (1848); Hemorrhage/Bleeding (1888); Transient Ischemic Attack (2109)

Event Date 11/18/2018

Event Type  Injury  

Event Description

Reporter states he found his mother unconscious on the bathroom floor bleeding from the back of her head.She was sent to er in which the dr believed it to be her coumadin, due to her bp being well maintained.The pt had a blunder to the back of her head, however, the bleeding was in fact due to a stroke.The dr was able to get her inr result from 1.8 to 1.1, taking her off of her blood thinners.The pt may need to have a left atrial appendage occlusion procedure in the near future.The reporter states they received a recall letter for this lot number.

• Brand Name: COAGUCHEK INR TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8129152
• MDR Text Key: 129396097
• Report Number: MW5081812
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 28631924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 97 YR
• Patient Weight: 43