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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

Patient Problems Ischemia (1942); Blurred Vision (2137); Dizziness (2194)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

The reporter's meter and test strips were requested for investigation.Test strip retention samples passed the internal inspection.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The reporter's meter and test strips were returned for investigation where they were tested using retention controls.Testing results (qc range = 2.1 - 3.3 inr): qc 1: 2.5 inr, qc 2: 2.5 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 maximum difference between measurements was 0%.Occupation - the occupation is lay user/patient.Unique device identifier (udi) (b)(4).

Event Description

It was reported that a patient continued her normal dose of warfarin medication based on results from coaguchek xs meter serial number (b)(4).The patient was later diagnosed with 2 mini-strokes.On (b)(6) 2021, this patient tested a sample using the meter, resulting in a value of 3.5 inr.On (b)(6) 2021, the patient tested a sample using the meter, resulting in a value of 3.8 inr.The patient's therapeutic range is 3.0 - 3.5 inr.The patient's testing frequency is once per week.After receiving the meter results, the patient continued to take warfarin as usual.On (b)(6) 2021, the patient had symptoms of blurry vision, was dizzy, and was light-headed.The patient reported this to her doctor and the doctor sent the patient to the emergency room.At the hospital on (b)(6) 2021, a sample from the patient was tested in the laboratory using an unknown method, resulting in a value of 2.2 inr.The patient received a brain scan test when she was admitted.The patient was diagnosed as having 2 mini-strokes occurring back to back.The patient was immediately started on heparin.The patient was then released from the hospital.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11401838
• MDR Text Key: 234408660
• Report Number: 1823260-2021-00643
• Device Sequence Number: 1
• Product Code: GJS
• 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: 03/02/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 04625374160
• Device Lot Number: 49408221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 03/02/2021
• 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
• Patient Outcome(s): Disability
• Patient Age: 73 YR
• Patient Weight: 52