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

Catalog Number 07671687019

Device Problem High Test Results (2457)

Patient Problems Numbness (2415); Ischemia Stroke (4418)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

One vial of test strip lot 47158811 containing >10 test strips was received for investigation.The test strips and vial showed no defects.The returned test strips were measured on reference meters with a high level control sample: control sample lot 455 699 00.Specified target range 2.7-3.3 inr (±11.5% around the lot specific target value of the complained test strip lot / control lot combination).Test 1: 3.0, test 2: 2.9, test 3: 3.0, all inr values were within the specified target ranges, confirming the functionality of the customer's coaguchek test strips.No error messages occurred.Routine retention testing was performed.Test strip retention samples passed the internal inspection.Additional information for assessment of the event was requested, but has not been received at this time.This event occurred in (b)(6).Initial reporter occupation: occupation was lay user/patient.Unique identifier (udi) # (b)(4).

Event Description

There was an allegation of questionable results from coaguchek xs meter serial number (b)(4).On (b)(6) 2021, the meter result was 4.4 inr.The doctor advised the patient to reduce the warfarin dose based on the coaguchek result.The warfarin dose was skipped once and the patient¿s inr returned to the normal range.No specific result was provided.No laboratory testing was performed.On (b)(6) 2021, the laboratory result using thromborel s reagent was 3.7 inr.No meter testing was performed.On (b)(6) 2021 at approximately 6 pm, the patient experienced a sudden loss of feeling in the leg and spoke to the doctor who suspected a tia and advised the patient to check the inr.The result from the meter was 2.9 inr.The patient took the normal warfarin dose between 6 pm and 7.30 pm.At 7.30 pm, the patient experienced a loss of feeling in the leg again and the doctor advised the patient to go to the hospital.At approximately 11:50 pm, the laboratory result using thromborel s reagent was 2.1 inr.On (b)(6) 2021, the result from the meter was 3.0 inr and the result within one hour from the laboratory using thromborel s reagent was 2.5 inr.There were no changes to medication based on these results.The therapeutic range was 2.5-3.5 inr.This mdr is being submitted in an abundance of caution.

Manufacturer Narrative

One vial of test strip lot 46589113 containing >10 test strips was received for investigation.The test strips and vial showed no defects.The returned test strips were measured on reference meters with a high-level control sample: control sample lot 455 699 00.Specified target range 2.7-3.3 inr (±11.5% around the lot-specific target value of the complained test strip lot/control lot combination).Test 1: 2.9 inr; test 2: 2.9 inr; test 3: 2.9 inr.All inr values were within the specified target ranges, confirming the functionality of the customer's coaguchek test strips.No error messages occurred.The medwatch fields a2 - age at time of event, a2 - date of birth, b6 - relevant test/laboratory data, and b7 - other relevant history were updated.The following additional information was received: the patient received vitamin k supplementation of 90 mcg when the meter reading 4.4 inr.This was continued for a couple of days.No specific dates were provided.The patient's testing frequency is intermittent and the meter is usually only used when the patient is traveling in remote locations.The patient's inr levels have been stable for twenty years and are usually within the desired range of 2.5 to 3.5 inr.The patient is currently taking 6.5mg of warfarin.A ct angiogram was performed showing the carotid arteries were clear.A ct of the brain was considered clear.A follow-up mri did not show any evidence of a stroke.The final diagnosis was a tia.The patient was hospitalized for one day in a short stay ward.Icu was not required.

• 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: 11892491
• MDR Text Key: 252906212
• Report Number: 1823260-2021-01577
• 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: 07/15/2021

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: 12/31/2021
• Device Catalogue Number: 07671687019
• Device Lot Number: 46589113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CANDESARTAN; TALINOLOL; WARFARIN; CANDESARTAN; TALINOLOL; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 62 YR