MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK VANTUS; PROTHROMBIN TIME MONITOR

Model Number COAGUCHEK INRANGE

Device Problems No Device Output (1435); High Test Results (2457)

Patient Problems Cardiac Enzyme Elevation (1838); Sepsis (2067); Urinary Tract Infection (2120); Dizziness (2194); Confusion/ Disorientation (2553)

Event Date 01/15/2021

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 meter was returned for investigation, where it was tested using retention test strips, retention controls, and retention batteries.Testing results (qc range 4.1 6.8 inr qc 1: 5.5 inr qc 2: 5.5 inr qc 3: 5.3 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%.It was determined that the patient¿s results were deleted prior to roche receiving the meter for investigation because the meter¿s patient result memory revealed no entries available.The patient was taking antibiotics.Product labeling states: the action of oral anticoagulants coumarin derivatives can be increased or weakened when other medication is taken simultaneously e.G.Antibiotics, but also prescription free medication like pain relievers, antirheumatic medication and medication against influenza.This, in turn, can also lead to either an increase or a decrease in prothrombin time (inr).If other medication is taken, it is recommended that the prothrombin time be checked more frequently and that the anticoagulant dose be subsequently adjusted.The customer alleged errors between (b)(6) 2020.To (b)(6) 2021.Errors observed in the meter's error log during this time frame are as follows: m-31 observed on (b)(6) 2021.At 11:47 pm, 11:48 pm, 11:50 pm, and 11:52 pm.This error occurs when the batteries are nearly empty and need replaced.Product labeling states: batteries are nearly empty.Replace batteries now.M-42 observed on (b)(6) 2020.At 4:11 am, 9:38 am, 11:55 pm, 11:58 pm, and 11:59 pm.This error occurs when there is not enough blood sample applied to the test strip.The error message asks for the customer to repeat test with a new test strip.Product labeling states: not enough sample was applied.Repeat test with a new test strip.M-44 observed on (b)(6) 2021.At 12:02 am.The internal qc of the strip has been failed, mostly caused by a wet test strip.This can be triggered if a test strip was dosed with sample and then inserted into the meter.Product labeling states test strip failed internal control.Repeat test with a new test strip.E-68 observed on (b)(6) 2020.At 11:50 pm.This error occurs when there is an unexpected interruption of the power supply, if empty batteries are in use, or the power is not strong enough to complete the measurement.Product labeling states: there was an unexpected interruption of the meter's power supply.Repeat your last procedure.The test strip guide cover was removed and the heater plate was heavily contaminated with dried blood.The user manual describes when and how to clean the meter.The customer stated that blood was collected from the patient's vein after a blood collection had occurred and used for meter testing.Per product labeling, venous blood must be applied to the strip within 30 seconds of collecting the blood.The customer did not provide information related to how the blood was collected, if it was properly collected, or if it was applied to the strip within 30 seconds.

Event Description

The initial reported stated that the coaguchek vantus material serial number (b)(4) was not working.Specifically, it was reported that the patient received w-45, m-44, e-51, e-62, and e-68 errors when trying to use the meter between (b)(6) 2020.And (b)(6) 2021, so the meter was unable to be used during this time.Product labeling states: repeat test with a new strip.If m-44 or w-45 error messages display repeatedly, you must use an alternative test method to confirm the result.Please contact your physician without delay.Also, in rare cases, patients with abnormal or unusually long clotting times may receive m-44 or w-45 error messages.The reporter also stated that the meter¿s batteries had to be changed multiple times in recent weeks.The reporter stated that when the patient was unable to use the meter to test, they would call an anticoagulation clinic to have someone come out and collect the patient's blood.Dosing during this time was done based on the laboratory result.It is unknown when these sample collections occurred or when the patient attempted to test with the meter.On approximately (b)(6) 2021, the reporter stated that the patient was taken to the emergency room due to dizziness and disorientation.A sample was collected from the patient in the emergency room and tested using an unknown method, resulting in a value of 6.4 inr.The patient was treated with vitamin k to lower his inr.The patient's warfarin was held for one day.The patient was then admitted to the hospital due to high inr and a urinary tract infection.The patient then had a blood infection.The patient is prone to urinary tract infections due to having a super catheter.The patient was given unknown intravenous antibiotics.The patient was in the hospital for two weeks with an infection.The patient's doctor did not know what caused the patient's high inr.This was during the timeframe in which the meter was not able to be used due to error messages and dosing was based on the laboratory results.The patient received an ultrasound to see if he had any bleeding.There was no bleeding present.The patient was released from the hospital on (b)(6) 2021.And was not taking antibiotics when discharged from the hospital.The patient was placed back on antibiotics while at home on approximately (b)(6) 2021.And stopped on approximately (b)(6) 2021.The patient took 1 antibiotic pill on approximately (b)(6) 2021.And another single pill on approximately (b)(6) 2021.On (b)(6) 2021, a sample from the patient was tested in the laboratory, resulting in a value of 2.4 inr.Using a blood sample that came out of a vein after the laboratory sample collection, this sample was tested using the meter, resulting in a value of 4.4 inr accompanied by a control bottle icon.Product labeling states the control bottle icon may occur if the hematocrit value is very low or due to erroneous blood collection e.G., wet hands.Make sure your hands are dry.Repeat the test.If the icon is displayed again, please contact your healthcare professional or seek immediate medical attention.The patient's therapeutic range is 2 3 inr.The patient's testing frequency was reported as twice per week.The patient used test strip lot number 44949822, with an expiration date of 30-jun-2021.This mdr is being submitted in an abundance of caution.

• Brand Name: COAGUCHEK VANTUS
• Type of Device: PROTHROMBIN TIME MONITOR
• 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: 11518553
• MDR Text Key: 245322504
• Report Number: 1823260-2021-00860
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170960
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: COAGUCHEK INRANGE
• Device Catalogue Number: 07729952160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 02/18/2021
• 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): Other
• Patient Age: 86 YR
• Patient Weight: 100