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

Catalog Number 04625315003

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Occupation is lay user/patient.The test strips were requested for investigation.The reporter returned two vials of test strips for investigation where they were tested using retention controls.Testing results (qc range: 2.6 - 3.2inr): vial #1: qc 1: 3.1 inr, qc 2: 3.0 inr, qc 3: 3.0 inr.Vial #2: qc 1: 3.0 inr, qc 2: 3.0 inr, qc 3: 2.9 inr.Relevant retention test strips (lot 409650) 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.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter complained of discrepant inr results with back to back tests on coaguchek xs meter serial number (b)(4).The result from the meter at 10:42 a.M.Was 1.9 inr.The result from the meter at 10:44 a.M.Was 2.6 inr.The patient's therapeutic range was 2.5 - 3.5 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: 9628263
• MDR Text Key: 217658773
• Report Number: 1823260-2020-00198
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 04625315003
• Device Lot Number: 40965011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Date Manufacturer Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 90