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

Catalog Number ASKU

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fainting (1847); Ischemia (1942)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

The reporter's product was requested for investigation.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.Test strip retention samples passed the internal inspection.Reporter occupation - the occupation is lay user/patient.This event occurred in (b)(6).

Event Description

The initial reporter stated she received a blood clot in her brain due to use of coaguchek xs meter serial number (b)(4).On the day of the event, a sample from the patient was tested using the meter, resulting with a value of 3.2 inr.At an unknown time on the same day, the patient was tested in the laboratory using an unknown method, resulting with a value of 2.69 inr.The reporter stated that coumadin medication adjustments were made based on incorrect results obtained from the meter.This led to the patient having a blood clot in the brain on (b)(6) 2020.The blood clot caused the patient to lose consciousness and speech.The patient has regained consciousness and is doing well again.The patient also regained her ability to speak.The patient's therapeutic target is a minimum of 3.0 inr.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested using retention controls.The meter appeared undamaged and clean on the outside.Results (qc range = 2.7-3.3 inr): qc 1 = 3.1 inr, qc 2 = 3.1 inr, qc 3 = 3.1 inr, all inr values were within the specified target ranges, confirming the functionality of the complained coaguchek meter.No error messages occurred.

• 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: 11226047
• MDR Text Key: 228662554
• Report Number: 1823260-2021-00252
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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 Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANORO; AZARGA; BELOC; COUMADIN; DESYREL; HYZAAR; KAPRIL; LASIX; MITRAL VALVE HEART; NORVASC; PAXIL; TEBOKAN; XALATAN; ANORO; AZARGA; BELOC; COUMADIN; DESYREL; HYZAAR; KAPRIL; LASIX; MITRAL VALVE HEART; NORVASC; PAXIL; TEBOKAN; XALATAN
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 65