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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem Coagulation Disorder (1779)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The reporter's product was requested for investigation and replacement product has been sent to the reporter.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Reporter occupation - the occupation is lay user/patient.

Event Description

The initial reporter stated that a patient received discrepant results when testing with coaguchek xs meter serial number (b)(4).The reporter also believed usage of the device led to the patient having a stroke.On (b)(6) 2020, back to back measurements were performed on the patient using the meter, resulting in values of 1.8 inr and 2.4 inr.On (b)(6) 2020, the patient had a meter result of 4.6 inr.After this measurement, the patient's warfarin medication was held for one day and then the normal dosage was resumed.The patient was admitted to the hospital on (b)(6) 2020 due to a stroke.The patient was hospitalized in the status of acute care.The reporter alleges the 4.6 inr measurement performed on (b)(6) 2020 was incorrect, leading the patient's warfarin dosage to be reduced and that this may have had a role in the patient's stroke.The patient's warfarin medication was increased on (b)(6) 2020 from 2 mg.To 2.5 mg.The patient's normal warfarin dose is 2.0 mg.The patient's warfarin medication was subsequently reduced to 1.5 mg.For one day, but the reporter was unable to specify when this change was made.At the emergency room, the patient had a computerized axial tomography scan and this was inconclusive.The patient received magnetic resonance imaging which confirmed an ischemic stroke occurred affecting the left side of the patient's brain, impacting her ability to communicate, move the fingers in her right hand entirely, and reducing the range of motion in her shoulder joint in the right arm.An examination of the patient's carotid artery was performed, resulting in no findings.The patient was discharged from the hospital and admitted to a rehabilitation facility on either the (b)(6) 2020 or (b)(6) 2020.At the rehabilitation facility, the patient received speech, occupational, and physical therapy.The patient was also experiencing atrial fibrillation.The patient was expected to remain at the rehabilitation facility until (b)(6) 2020.At the rehabilitation facility, the patient's inr is tested daily.The patient was diagnosed with lupus antibodies approximately two or three months prior to (b)(6) 2020.Per product labeling: "the presence of anti-phospholipid antibodies (apas) such as lupus antibodies (la) can potentially lead to prolonged clotting times, i.E., they may cause false-high inr values.If you have or suspect that you have apas, contact your doctor and do not continue inr testing with this device." the therapeutic range was 2.5 - 3.5 inr and the patient's testing interval is weekly.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention test strips and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.0 inr, qc 2: 5.2 inr, qc 3: 5.0 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 maximum difference between measurements was 4%.

Manufacturer Narrative

Medwatch field b2.Has been updated.

Manufacturer Narrative

Evaluation conclusion code updated.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10904893
• MDR Text Key: 218913183
• Report Number: 1823260-2020-03012
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2021

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: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 04625374160
• Device Lot Number: 44502621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 10/29/2020; 10/29/2020; 10/29/2020
• Supplement Dates FDA Received: 12/03/2020; 12/16/2020; 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MECHANICAL HEART VALVE (MITRAL VALVE).; MEDICATION FOR LUPUS.; WARFARIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR