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 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient's husband stated that the patient received erroneous results when testing with coaguchek xs meter serial number (b)(4) on (b)(6) 2018.He provided results that were in the memory of the meter.On (b)(6) 2018 at 6:41 p.M., a sample from the patient resulted as 3.5 inr when tested on the meter.On (b)(6) 2018 at 6:44 p.M., a sample from the patient resulted as 2.3 inr when tested on the meter.On (b)(6) 2018 at 6:46 p.M., a sample from the patient resulted as 1.8 inr when tested on the meter.An additional value of 2.6 inr was provided for the value on (b)(6) 2018 at 6:44 p.M.It was asked, but it is not known if this represents an additional value or if it was provided in error.A clarification has been requested.On (b)(6) 2018 at 8:57 a.M., a sample from the patient resulted as 7.0 inr when tested on the meter.On (b)(6) 2018 at 9:02 a.M., a sample from the patient resulted as 2.6 inr when tested on the meter.The patient's husband said he lanced a different finger for the second test on (b)(6) 2018.No adverse events were alleged to have occurred with the patient.No treatment was provided to the patient based on the meter results.The patient's therapeutic range is 2.0 - 3.0.The patient is not anemic and does not have antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors.The patient's coumadin dosage has not changed.The patient has had no changes in medications or diet.The patient has had no illnesses, bleeding, bruising, or serious injuries.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 272163-21) were tested.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 and test strips were returned for investigation.The returned meter and test strips were tested in comparison to a retention meter and master lot strips.Two human blood samples from warfarin donors and internal reference meters were used.Donor 1 inr: 2.6 inr.Donor 2 inr: 2.6 inr.Donor 1 hct: 44%.Donor 2 hct: 54%.Testing results: donor 1: retention meter with master lot strips: 2.6 inr.Customer meter with customer strips: 2.7 inr.Donor 2: retention meter with master lot strips: 2.6 inr.Customer meter with customer strips: 2.6 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, the following additional erroneous results were observed: on (b)(6) 2016 at 22:12, there was a value of 4.7 inr.On (b)(6) 2016 at 22:18, there was a value of 6.0 inr.On (b)(6) 2016 at 22:40, there was a value of 2.5 inr.On (b)(6) 2016 at 13:49, there was a value of 3.1 inr.On (b)(6) 2016 at 13:51, there was a value of 2.2 inr.On (b)(6) 2017 at 17:26, there was a value of 4.1 inr.On (b)(6) 2017 at 17:32, there was a value of 2.4 inr.On (b)(6) 2018 at 10:00, there was a value of 4.7 inr.On (b)(6) 2018 at 10:13, there was a value of 2.8 inr.

Manufacturer Narrative

In relation to this information: "on (b)(6) 2018 at 6:44 p.M., a sample from the patient resulted as 2.3 inr when tested on the meter." for this value, the customer provided a value of 2.6 inr.The meter memory indicates a value of 2.3 inr was measured at this time and date.

Manufacturer Narrative

Based on the meter memory, the value on (b)(6) 2018 at 6:44 p.M was actually 2.3 inr, rather than the 2.6 inr provided by the customer and reported in the initial mdr.

• 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: 7381965
• MDR Text Key: 104149624
• Report Number: 1823260-2018-00956
• 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,Followup,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 27216321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2018
• 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: 78 YR
• Patient Weight: 82