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

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of questionable inr results for 1 patient from two coaguchek xs meters, serial numbers (b)(4).At 09:45 the result from meter (b)(64 was 2.7 inr.The result in the laboratory was 3.5 inr.The method was not provided.The measurements were all within 3 minutes.There was no allegation of an adverse event.The customer did not believe the results from the meters.The patient's therapeutic range was 2.5 - 3.5 inr.The customer's meters were tested with strip lot 29494211 in comparison to a retention meter using qc material.No issues were observed and all of the results were within range.Relevant retention test strips were tested in comparison with the master lot coaguchek xs pt.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.The suspect product was requested to be returned for investigation.

Manufacturer Narrative

The customer strips were returned for investigation.The returned test strips were measured 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: 2.4 inr, reference meter with customer strips: 2.4 inr.Donor 2: reference meter with masterlot strips: 7.0 inr, reference meter with customer strips: >8.0 inr.The maximum difference between measurements with the same blood sample was 14 %.Returned customer material and retention material comply with 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: 7548597
• MDR Text Key: 109905012
• Report Number: 1823260-2018-01622
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SERETIDE; WARFARIN