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 Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient stated that she received erroneous results when testing with coaguchek xs meter serial number (b)(4).The customer uses capillary tubes for sample collection.At 4:31, a sample from the patient was tested on the meter, resulting as > 8.0 inr.At 4:42 p.M., a sample from the patient was tested on the meter, resulting as 1.4 inr.At 4:50 p.M., a sample from the patient was tested on the meter, resulting as 2.0 inr.When obtaining samples, the time elapsed between the fingerstick and application of sample to the test strip was longer than 15 seconds.On (b)(6) 2018, a sample from the patient was tested using an unknown laboratory method and this result was 2.1 inr.No adverse events were alleged to have occurred with the patient.The patient did not receive any treatment based on the meter results.The patient's therapeutic range is 2 - 3 inr.The patient has been taking 6 mg.Of warfarin daily for the last 3 weeks.The patient does not take heparin or direct thrombin inhibitors.The patient has had no changes in diet, no recent illnesses, and no new medications.The patient did not have any special or unusual diet.The patient has not had any bleeding.She stated that she bruises easily, but it was nothing that required treatment.The meter had not been cleaned under the strip guide cover.There were no visible signs of dirt, blood, or debris.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 2167482) were tested in comparison with the master lot test strips.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were within specifications.

Manufacturer Narrative

The customer did not return any materials for investigation.The investigation was unable to find a definitive root cause.

• 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: 7260230
• MDR Text Key: 100062664
• Report Number: 1823260-2018-00388
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 04625374160
• Device Lot Number: 2167482
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUBAGIO; WARFARIN