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 Problems Speech Disorder (4415); Ischemia Stroke (4418)

Event Date 05/24/2022

Event Type  Injury  

Event Description

We received an allegation that a patient had a stroke while coaguchek xs meter serial number (b)(4) was in use.Prior to the stroke, the patient¿s therapeutic range was allegedly 3.0 ¿ 4.0 inr.Following the stroke, the patient¿s therapeutic range is allegedly 2.0 ¿ 3.0 inr.The patient reportedly tests weekly but is allegedly "not always" compliant.On approximately (b)(6) 2022 the patient had reportedly not been feeling well.The patient¿s doctor had allegedly suspected a stroke and the patient had gone to the emergency room (er) for an x-ray.The patient was reportedly "cleared" at the er and was advised to go home.On (b)(6) 2022 the meter result from the patient¿s logbook was reportedly 5.2 inr at 9:15 a.M.The reporter did not know if there was a change made to the patient's warfarin dose based on this result.On (b)(6) 2022 the patient¿s daughter reportedly found the patient sitting on the couch staring at the ceiling and talking "gibberish." the patient¿s daughter called 911 and the patient was transported to the hospital via ambulance.The reporter did not know the patient¿s inr results upon admission to the hospital.The patient reportedly had a computerized tomography (ct) scan and a blood clot was confirmed.The reporter did not know where the blood clot was located.The reporter believes a clot caused the stroke.The reporter did not know the type of treatment received or any inr results during the hospitalization.The reporter has allegedly not been told what contributed to the stroke.The patient was reportedly in the hospital for one week and then in rehabilitation for two weeks.Prior to the stroke, the patient¿s warfarin dose was allegedly "changing frequently." for example, in early (b)(6) 2022 the patient would reportedly take 4 mg warfarin monday, tuesday, and wednesday.On thursday the patient would not take any warfarin and on friday, saturday, and sunday the patient would take 2 mg.These dosages could allegedly change based on the meter results.Following the stroke, they are not making "frequent" changes to the patient¿s warfarin dose anymore.The patient is currently in stable condition.Following the stroke, the patient has full mobility but still has speech impairment.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

Initial reporter occupation: occupation is patient/consumer (patient's daughter).The meter and test strips were requested for investigation, however, the test strips have been discarded.The 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: 5.5 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The alleged results were not able to be observed in the meter's patient result memory due to the meter's time and date not being set correctly.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.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 15631327
• MDR Text Key: 301985804
• Report Number: 1823260-2022-03244
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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
• Date Manufacturer Received: 09/19/2022
• 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: AMIODARONE; ATORVASTATIN; BABY ASPIRIN; CARVEDILOL; CLARITIN; LASIX; LEVOTHYROXINE; LOSARTAN; PROBIOTIC; PROTONIX; TRAZODONE; WARFARIN
• Patient Outcome(s): Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 68 KG