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 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4), device not returned.

Event Description

The patient stated that she received erroneous results when testing with coaguchek xs meter serial number (b)(4).The patient called stating that she had a result of 8 and that it was in units of % quick.The patient was advised to change the units of measure to inr.After doing this, the patient saw the result and it was 6.0 inr, which was considered high.The patient stated that she tested twice and got the same result.Upon review of the meter memory, the patient had tested twice at 5:30 p.M.And the results were 4.2 inr and 6.0 inr.The second test was performed immediately after the first test and a different finger was used to obtain the sample.No adverse events were alleged to have occurred with the patient.The physician was informed of both meter values and instructed the patient to hold warfarin/coumadin dosage that night and the next day.No other treatment was provided to the patient.The patient's therapeutic range is 2.0 - 3.0 inr.The patient is tested once per week.The patient is not anemic or polycythemic.The patient does not have antiphospholipid antibodies or lupus.The patient does not take heparin or direct thrombin inhibitors.The patient's warfarin/coumadin dose had been increased as her result the week prior was 1.2 inr.The patient has not had any changes in diet, no new medications, and no new illnesses.The patient did not have any special or unusual diet.The meter had not been cleaned recently.The patient's product was requested for investigation and replacement product was sent to the patient.The patient stated that there were no more test strips available to be returned.Relevant retention test strips (lot 235476-21) 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 was 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: 2.8 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.Upon review of the meter memory, results of 4.2 inr and 6.0 inr were present, but the date performed could not be verified as (b)(6) 2018 as the meter date was set incorrectly.

• 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: 7320204
• MDR Text Key: 102123728
• Report Number: 1823260-2018-00676
• 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: 11/30/2018
• Device Catalogue Number: 04625374160
• Device Lot Number: 23547621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• 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: 86 YR