MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

Patient Problems Stroke/CVA (1770); Insufficient Information (4580)

Event Date 06/27/2020

Event Type  Injury  

Manufacturer Narrative

The customer's meter was requested for investigation.The test strips used at the time of the event have been used up, so these were not available to send for investigation.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.Occupation - the occupation is patient/consumer.

Event Description

It was alleged that a patient had several transient ischemic attacks (tia) in 2020 while using coaguchek xs meter serial number (b)(4).The estimated date of the event is (b)(6) 2020.The actual date is unknown.The patient's therapeutic range is reported to be 3.0 - 3.5 inr.It was reported on (b)(6) 2022 that the patient has had her current coaguchek meter for approximately 2 years.The patient allegedly last tested on the meter on (b)(6) 2022 and the result was reportedly 3.8 inr.The patient reportedly received her first coaguchek meter in 2000 as a result of a stroke.The patient has allegedly had several mini-strokes since having the meter.The last mini-stroke tia was reported to have occurred approximately 2 years ago.The patient allegedly has short-term memory loss and cannot drive anymore because of the strokes.The patient was reportedly not admitted to the hospital at that time.The following information was requested, but could not be provided as the reporter could not recall any further details of these events: the patient's inr prior to the stroke.The patient's inr at the time of the stroke.Details related to the stroke, including therapy provided.Information on other medications the patient was taking.This mdr is being submitted in an abundance of caution.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15103237
• MDR Text Key: 296580118
• Report Number: 1823260-2022-02195
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 00365702127104
• UDI-Public: 00365702127104
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2022

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2022
• Initial Date FDA Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WARFARIN
• Patient Outcome(s): Other
• Patient Sex: Female