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 Known Impact Or Consequence To Patient (2692)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

The patient stated that he received erroneous results when testing with coaguchek xs meter serial number (b)(4).The patient tested a sample on the meter and the result was 6.8 inr.Within 4 minutes, the patient tested a sample collected from the same finger on the meter and the result was 4.5 inr.No adverse events were alleged to have occurred with the patient.The patient did not receive treatment based on the meter results.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is weekly.The patient does not have antiphospholipid antibodies or anemia.The patient did not have any changes in medication or diet.The patient did not have any special or unusual diet.The patient has not had any change in recent illnesses.The patient did not have bruising, but has seen bruising in the past.No medical treatment was sought for the bruising.The patient did not use alcohol on his finger prior to sample collection.The patient's product was requested for investigation and replacement product was sent to the patient.The patient's test strip vial had been depleted and discarded, so it will not be available for investigation.Relevant retention test strips (lot 266834) 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 samples were within specifications.The patient's meter was returned for investigation.The returned meter and master lot strips were tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.4 inr.Donor 2 inr: 2.9 inr.Donor 1 hct: 45%.Donor 2 hct: 38%.Testing results: donor 1: retention meter with master lot strips: 2.4 inr.Customer meter with master lot strips: 2.4 inr.Donor 2: retention meter with master lot strips: 2.9 inr.Customer meter with master lot strips: 2.9 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.Product labeling instructs the patient to never perform another test with blood from the same puncture site.Upon review of the meter memory, the following erroneous results were also observed: on (b)(6) 2018 at 13:17, the patient had a result of 3.7 inr.On (b)(6) 2018 at 13:22, the patient had a result of 2.6 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: 7320767
• MDR Text Key: 102123758
• Report Number: 1823260-2018-00697
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 266834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 96