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

Catalog Number 04625358003

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The patient called to complain that she believes her coagucheck xs meter with serial number (b)(4) was not measuring correctly.The patient says that the meter result was different from results obtained with an unknown laboratory method.Upon evaluation of the provided patient data, it was determined that the patient had erroneous results on the meter on (b)(6) 2016.At 12:37, the patient had a meter result of (b)(4)% quick.At 12:39, the patient had a meter result of (b)(4)% quick.The patient was asked, but could not remember any issues with result deviations occurring in (b)(6) 2016.It was asked, but it is not known if the patient had any adverse events related to this event.On (b)(6) 2016, it was stated that the patient has had no new medication and does not take heparin.The patient's therapeutic range is 25% - 35% quick.The customer provided the meter and test strip lot number 206231-12, with an expiration date of 03/31/2017 for investigations.The test strip lot number and expiration date that were in use during the event are not known.Retention test strips (lot 206231-10) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Donor 1: reference meter and retention strips - 2.6 inr.Reference meter and master lot strips - 2.7 inr.Donor 2: reference meter and retention strips - 1.7 inr.Reference meter and master lot strips - 1.7 inr.No error messages occurred.The retention material was found to be within specifications.Upon investigation of the returned material, the returned test strips and vial showed no defects.The returned meter appeared undamaged and clean on the outside.The returned test strips were measured with the returned meter in comparison with retention test strips (lot 206231-10) and the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and internal reference meters were used.Donor 1: reference meter and master lot strips - 2.2 inr.Customer meter and customer test strips - 2.2 inr.Donor 2: reference meter and master lot strips - 2.4 inr.Customer meter and customer test strips - 2.5 inr.The returned customer material and retention material are within specifications.

Manufacturer Narrative

A full medical assessment could not be performed based on the provided information.Additional information required for the investigation was requested, but not provided.Essential thrombocythemia is a blood disorder characterized by overproduction of platelets and is related to increased risk of vascular and thrombotic events.In this case, it cannot be excluded if the thrombotic episode was caused or contributed by the primary disease or if it was related to the anticoagulation therapy/monitoring.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6197898
• MDR Text Key: 63198053
• Report Number: 1823260-2016-02045
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

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 Catalogue Number: 04625358003
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MARCUMAR
• Patient Age: 65 YR