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

Catalog Number 04625315019

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's meter and test strips were requested for investigation.The customer's test strips were returned for investigation and they were measured on reference meters with a high level control sample.Testing results (qc range: 2.6 - 3.2 inr): qc 1: 3.0 inr, qc 2: 3.0 inr, qc 3: 3.0 inr.All inr values were within the specified target ranges, confirming the functionality of the complained coaguchek test strips.No error messages occurred.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Occupation is lay user/patient.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable results from coaguchek xs meter serial number (b)(4) compared to a laboratory result using an unknown method.The meter result was 6.1 inr.The laboratory result was 4.4 inr.The results were taken approximately 1-1.5 hours apart.The customer's therapeutic range is 2.0-3.0 inr.

• 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: 10470806
• MDR Text Key: 204879913
• Report Number: 1823260-2020-02132
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2020

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: 10/31/2020
• Device Catalogue Number: 04625315019
• Device Lot Number: 40158611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/31/2020
• 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: WARFARIN