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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation is lay user/patient.The test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Relevant retention test strips (lot 409638) 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 investigation did not identify a product problem.The cause of the event could not be determined.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.

Event Description

The initial reporter complained of discrepant inr results with coaguchek xs meter serial number (b)(4), compared to an unknown laboratory method.The result from the laboratory at 8:20 a.M.Was 2.24 inr.The result from the meter at 8:38 a.M.Was 3.1 inr.The laboratory result was believed and there was no treatment provided.The patient's therapeutic range was 2.0 - 3.0 inr.

Manufacturer Narrative

The reporter's test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.4 ¿ 3.6 inr): qc 1: 3.1 inr.Qc 2: 3.1 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.The maximum difference between measurements was 0%.Medwatch fields d10 and h3 have been updated.

• 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: 9637402
• MDR Text Key: 220024400
• Report Number: 1823260-2020-00213
• 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
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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: 04625374160
• Device Lot Number: 40963821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIOTIN; CALTRATE SOFT CHEWS CALCIUM WITH VITAMIN D; WARFARIN
• Patient Age: 51 YR