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

Catalog Number 07671687003

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).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).At 11:26 a.M., the patient tested on her meter and the result was 7.5 inr.At 11:29 a.M., the patient tested on her meter and the result was 7.5 inr.At 12:57 p.M., the patient tested on her meter and the result was 8.0 inr.The patient immediately called emergency services and was taken to the hospital.At approximately 02:00 p.M., a sample from the patient was tested on the hospital coaguchek meter and the result was 5.8 inr.At 02:15 p.M., the patient was tested on the hospital coaguchek meter and the result was 5.3 inr.The patient was in the hospital for about 2 to 3 hours.The patient's blood pressure was checked and marcumar medication was measured.The patient received one ampule of vitamin k medication.The patient was discharged from the hospital.When the patient was back at home, she tested on her meter at 06:16 p.M.And the result was 7.2 inr.At 08:44 p.M., the patient tested on her meter and the result was 5.9 inr.On (b)(6) 2018 at 02:05 a.M., the patient tested on her meter and the result was 2.8 inr.At 05:52 a.M., the patient tested on her meter and the result was 2.2 inr.At 12:39 p.M., the patient tested on her meter and the result was 1.7 inr.At 05:46 p.M., the patient tested on her meter and the result was 1.5 inr.No adverse events were alleged to have occurred with the patient.The patient's product has been requested for investigation.Relevant retention test strips (lot 286320) 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.Retention samples were within specifications.No error messages occurred.

Manufacturer Narrative

The meter and strips were returned for investigation.The returned test strips were measured with the returned meter in comparison with the current test strip master lot.For this purpose two human blood samples from marcumar donors and internal reference meters were used.Testing results: donor 1: reference meter with masterlot strips: 2.0 inr, customer meter with customer strips: 2.0 inr.Donor 2: reference meter with masterlot strips: 2.6 inr, customer meter with customer strips: 2.6 inr.The maximum difference between measurements with the same blood sample was 0 %.Returned customer material and retention material comply with the specification.

• 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: 7556938
• MDR Text Key: 110047644
• Report Number: 1823260-2018-01680
• 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: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• 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: 07671687003
• Device Lot Number: 28632011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Date Manufacturer Received: 05/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMIODARON (1-0-1); AMITRIPTYLIN (ACCORDING TO SCHEDULE); ARTIFICIAL HEART VALVE; CANDESARTAN (1-0-1); EZETINIB (0-0-1); MAGNISUM (1-1-1); MARCUMAR (ACCORDING TO SCHEDULE); METAMIZOL (4 X 40 TRICKLE); METOPROLOL (1-0-0); PANTOPRAZOL (1-0-0); PEMAZEPA (0-0-1); PILIDIN (1-0-1); TIOTROPION (0-0-1); TORASEMID (1-1-0)
• Patient Age: 79 YR
• Patient Weight: 84