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

Catalog Number 04625374160

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation - the occupation is lay user/patient.

Event Description

The patient stated that he received an erroneous result when testing with his coaguchek xs meter serial number (b)(4).A sample from the patient was tested using the meter at 8:57 a.M., resulting with a value of 4.4 inr.The doctor advised the patient to come into the doctor's office for another test.At around 2:15 p.M., a sample from the patient was tested using the doctor's coaguchek xs meter, resulting with a value of 1.5 inr.The doctor believed the 1.5 inr value to be correct.No adverse events were alleged to have occurred with the patient.The patient was not treated and did not have medication changed based on the meter result.The patient is currently feeling well.The patient stated that the doctor wants his inr levels to stay around 2.0 inr.The patient stated that the doctor is okay with an inr of 2.2, but not much higher than this.The patient's testing frequency is once per week.The patient is not anemic or polycythemic.The patient does not have antiphospholipid antibodies or lupus.The patient does not take heparin or direct thrombin inhibitors.The patient was taking 2.5 mg of warfarin per day.Due to a 4.0 inr result on (b)(6) 2018, the patient withheld warfarin on (b)(6) 2018.On (b)(6) 2018, the patient began rotating warfarin medication between 1.25 mg.And 2.5 mg.Every other day.The patient is not taking any new medications and has no new illnesses.The patient said that he had no changes in diet other than eating less lately.The patient had a nosebleed, but did not need medical treatment.The patient's product was requested for investigation.Relevant retention test strips (lot 353497) were tested in comparison with the master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.

Manufacturer Narrative

The patient's meter was returned for investigation and was tested with qc material in combination with master lot strips.Testing results: qc 1: 2.6 inr, qc 2: 2.5 inr, qc 3: 2.6 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.(1.9 - 2.9 inr).All measurements were without error messages.The maximum difference between measurements was 8.3 %.The results alleged by the customer were not observed in the meter¿s patient result memory.

• 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: 8203744
• MDR Text Key: 131772986
• Report Number: 1823260-2018-05165
• 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
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 04625374160
• Device Lot Number: 35349723
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATRIAL VALVE REPLACEMENT; COLCHICINE; FUROSEMIDE; METOPROLOL; PACEMAKER/ICD; PANTOPRAZOLE; RANITIDINE; TAMSULOSIN; ULORIC
• Patient Age: 81 YR