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

Catalog Number 04625358003

Device Problems Incorrect Or Inadequate Test Results (2456); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The patient stated that he received erroneous results when testing with coaguchek xs meter serial number (b)(4).The patient measured the following values within 2 hours when testing capillary blood samples with the meter: 4.9 inr, 6.5 inr, and 5.7 inr.No adverse events were alleged to have occurred with the patient.The patient's condition is currently very good.The patient's therapeutic range is 3.1 - 3.5 inr.The patient does not have "ass", does not take antibiotics, does not take pain killers, and does not use disinfectants.The patient suffered a stroke 3 years ago and the therapeutic range of the patient was changed at that time after consultation with the doctor.The patient's prior therapeutic range was 2.5 - 3.0 inr.The patient's product was requested for investigation.Relevant retention test strips (lot 286321) 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 within specifications.No error messages occurred.Upon review of the meter memory, the complained values are each dated (b)(6) 2003 and were measured at the following times: 4.9 inr at 11:13; 5.7 inr at 11:28; 6.5 inr at 11:42.In the memory, there is a value of 5.9 inr measured at 00:57 on (b)(6) 2018.The following discrepancies were also observed in the meter memory: on (b)(6) 2002 at 12:43, the patient had a value of 3.3 inr.On (b)(6) 2002 at 12:51, the patient had a value of 2.3 inr.On (b)(6) 2002 at 13:29, the patient had a value of 3.8 inr.On (b)(6) 2002 at 13:35, the patient had a value of 2.7 inr.On (b)(6) 2002 at 10:20, the patient had a value of 3.4 inr.On (b)(6) 2002 at 10:31, the patient had a value of 2.6 inr.On (b)(6) -2003 at 12:48, the patient had a value of 2.9 inr.On (b)(6) 2003 at 12:53, the patient had a value of 1.0 inr.On (b)(6) 2003 at 11:52, the patient had a value of 1.5 inr.On (b)(6) 2003 at 11:58, the patient had a value of 3.2 inr.On (b)(6) 2003 at 11:07, the patient had a value of 3.0 inr.On (b)(6) 2003 at 11:17, the patient had a value of 1.9 inr.On (b)(6) 2003 at 07:29, the patient had a value of 1.0 inr.On (b)(6) 2003 at 07:40, the patient had a value of 2.5 inr.

Manufacturer Narrative

The patient's meter and strips was returned for investigation.The returned meter and strips were tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Testing results: donor 1: retention meter with master lot strips: 2.9 inr, customer meter with customer strips: 2.9 inr.Donor 2: retention meter with master lot strips: 2.3 inr, customer meter with customer strips: 2.4 inr.The maximum difference between measurements with the same blood sample was 4%.Returned customer material and retention material comply with the specification.Complained lot and meter have fulfilled the release criterion of product control.

Manufacturer Narrative

Extensive measurements have shown higher deviations for coaguchek values > 4.5 inr compared to a laboratory method.Therefore, the customer allegation has been substantiated.A product problem has been found for coaguchek values > 4.5 inr, which was the case in this complaint.This can be traced back to the calibration of the complained test strips to the who standard rtf/16.For measurements > 4.5 inr.The customer is advised to contact the physician and perform a measurement with a laboratory method.Roche diagnostics has issued a recall for this issue.Correction/removal report no.

• 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: 7651426
• MDR Text Key: 113187297
• Report Number: 1823260-2018-02147
• 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,Followup
• Report Date: 10/05/2018

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: 06/30/2019
• Device Catalogue Number: 04625358003
• Device Lot Number: 28632111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/15/2018; 06/15/2018
• Supplement Dates FDA Received: 08/03/2018; 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-08/30/18-005-C
• Patient Sequence Number: 1
• Treatment: ARTIFICIAL HEART VALVE; BISOPROL; LEXIUM; MARCUMAR
• Patient Age: 79 YR