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

Catalog Number 04625374160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The patient stated that she received erroneous results when testing with coaguchek xs meter serial number (b)(4).The patient started using the meter in (b)(6) 2015.At 6:13 p.M., a sample from the patient was tested on the meter, resulting as 6.7 inr.At 6:21 p.M., a sample from the patient was tested on the meter, resulting as 4.4 inr.At 6:27 p.M., a sample from the patient was tested on the meter, resulting as 8.0 inr.The patient stated that there was then an error with the battery.The patient changed the battery in the meter and found that the date was not correct.It was set to (b)(6) 2000.The patient then tested two more times with the meter.A sample from the patient was tested on the meter at 12:01 p.M.On (b)(6) 2000 (according to the meter memory), resulting as 5.5 inr.A sample from the patient was tested on the meter at 12:09 p.M.On (b)(6) 2000 (according to the meter memory), resulting as 7.5 inr.The patient collected all samples from two fingers, but each sample was collected from a fresh fingerstick.No adverse events were alleged to have occurred with the patient.The patient did not receive any treatment and medication was not changed.The patient's current condition is okay.The patient's therapeutic range is 2.5 - 3 inr.The patient's testing frequency is once per week if within therapeutic range.The patient is not anemic or polycythemic.The patient did not have antiphospholipid antibodies.The patient does not take heparin, lovenox, or thrombin inhibitors.The patient did not have any changes in diet, medications, or illnesses.The patient did not have any special or unusual diet.The patient had no bruising or bleeding.The meter had not been cleaned under the blue lid.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 281241) were tested in comparison with the current master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable.Upon review of the meter memory, the following additional discrepancies were observed: on (b)(6) 2017 at 23:00, the patient had a result of 6.1 inr.On (b)(6) 2017 at 23:03, the patient had a result of 4.6 inr.On (b)(6) 2000 at 12:09, the patient had a result of 1.8 inr.On (b)(6) 2000 at 13:02, the patient had a result of 3.1 inr.

Manufacturer Narrative

The patient's meter was returned for investigation.The returned meter and masterlot strips were tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 3.0 inr, donor 2 inr: 2.7 inr.Donor 1 hct: 58%, donor 2 hct: 58%.Testing results: donor 1: retention meter with masterlot strips: 3.0 inr, customer meter with masterlot strips: 3.0 inr.Donor 2: retention meter with masterlot strips: 2.7 inr, customer meter with masterlot strips: 2.7 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.

• 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: 7660022
• MDR Text Key: 113395934
• Report Number: 1823260-2018-02190
• 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: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 28124121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 MECHANICAL HEART VALVES; BREO ELLIPTA; CARDIZEM; CONTINUOUS POSITIVE AIR PRESSURE DEVICE; ESCITALOPRAM; LASIX; LEVOTHYROXIDE; METOPROLOL; MIRAPEX; OXYGEN; POTASSIUM CHLORIDE; WARFARIN
• Patient Age: 77 YR
• Patient Weight: 57