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

Catalog Number 04625374160

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhagic Stroke (4417)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Only the reporter's meter was provided for investigation where it was tested using retention strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.5 inr, qc 2: 5.5 inr, qc 3: 5.4 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.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.Per product labeling for error 6: the test strip was touched or removed during the test.Turn the meter off and remove the test strip.Repeat the test using a new test strip and blood taken from a new fingerstick from a different finger.Do not touch or remove the test strip when a test is in progress.Note: for meters with serial number up0910000 and lower: in rare cases, "error 6" may indicate extremely high coagulation times (> 10 inr, < 5% quick).If "error 6" is displayed repeatedly, please contact your physician without delay.Error 6 occurs due to errors in operation by the operator, e.G.When the test strip was moved or re-moved during the measurement if a wet test strip was used, when the on/off button is pressed during measurement, or the strip was already used before and reinserted.Product labeling states: you may see the following error messages while using the coaguchek xs meter.If you see an error message, first try to correct the problem using the solution described below.If the problem persists, call the roche customer support center at 1-800-428-4674, monday through friday from 7 am to 11 pm est.No error 6 was documented in the meter error log in (b)(6) 2022.A review of the meter result memory showed no results obtained in (b)(6) 2022.The first result documented in the meter result memory was (b)(6) 2022.Occupation was patient/consumer.

Event Description

On (b)(6) 2022, the reporter alleged the patient was unable to test on the coaguchek xs meter during the month of june as he was reportedly receiving an error 6 and alleged this may have led to a stroke and bleeding events.The reporter did not know how many attempts were made to get a result but alleged the patient used all the strips in two vials.The reporter confirmed the patient was having issues with the meter prior to the events.When attempting to test, the patient allegedly had a convulsive seizure.The seizure event occurred on an unknown date in (b)(6) 2022.A date of (b)(6) 2022 was used as an approximation.The reporter stated that the seizure had nothing to do with the device.The reporter did not remember when the patient had last successfully tested on the meter prior to the seizure event.Allegedly, the patient's wife took him to the hospital, and he became unresponsive.When they arrived at the hospital, testing was allegedly performed that confirmed he had a stroke.The reporter did not remember the stroke type or the name of the test that confirmed the stroke.The patient alleged he received a ct scan that showed he had a brain tumor and a mass on his kidneys.The patient alleged he has been having seizures for two years and he believed they are caused by a brain tumor.Allegedly, he had surgery to remove the tumor.The reporter alleged he did not know if the procedure was a burr hole or a device to measure brain pressure.The patient alleged the stroke could have been caused by bleeding around the tumor.The patent allegedly was in the icu for approximately two weeks and also had a gi bleed while in the hospital and received 3 or 4 units of blood.The patient was then sent to rehab where he allegedly had a heart attack.The patient alleged the heart attack was caused by receiving 3 or 4 units of blood.No other specific information about the medical treatment received could be provided.The reporter could not provide any inr results from the period of the events.The patient was currently in stable condition.The patient alleged that the corner of his mouth droops and he has no strength.The therapeutic range was 2.5-3.5 inr.The testing frequency was not provided.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: 15822936
• MDR Text Key: 303912300
• Report Number: 1823260-2022-03667
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 04625374160
• Device Lot Number: 58944025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Date Manufacturer Received: 10/18/2022
• 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: KEPRA; LISINOPRIL; WARFARIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 117 KG