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

Catalog Number 04625374160

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of discrepant inr results on coaguchek xs meter serial (b)(4).The customer initially tested at 8:42 a.M.With a result of 3.9 inr.The customer re-tested using a new finger at 8:57 a.M.And the result was 2.8 inr.The customer's therapeutic range is 2.0 ¿ 2.2 inr.No treatment was necessary.No adverse event occurred.The customer feels ok.The customer is not anemic and does not have antiphospholipid antibodies.The customer is not on heparin or other direct thrombin inhibitors.There has been no change in the customer's warfarin dose.The customer is not taking any new medications and there have been no changes in his diet.The customer has not been ill recently.The meter and test strips were requested for investigation.Relevant retention test strips (lot 258638-22) were tested in comparison with the current master lot.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention material was acceptable.

Manufacturer Narrative

The customer's meter was received for investigation.The customer's meter was tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.3 inr, donor 2 inr: 2.3 inr.Donor 1 hct: 35%, donor 2 hct: 36%.Testing results: donor 1: retention meter with master lot strips: 2.3 inr, customer meter with master lot strips: 2.3 inr.Donor 2: retention meter with master lot strips: 2.3 inr, customer meter with master lot strips: 2.3 inr.Results: all inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.All alleged results by the customer were observed in the meter¿s patient result memory (attached to the case).-customer received an error 5.This means not enough blood was applied to the strip.According to the product labeling not applying enough blood to the strip will result in an error 5.No information was provided in the complaint case that would point to a cause for the result discrepancy.

• 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: 7400556
• MDR Text Key: 104895576
• Report Number: 1823260-2018-01077
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 25863822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECOTRIN; FELODIPINE; LISINOPRIL; METOPROLOL; WARFARIN
• Patient Age: 71 YR
• Patient Weight: 79