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 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient stated that she received erroneous results when testing with coaguchek xs meter serial number (b)(4).At 11 a.M., the patient tested herself twice with the meter and each time the result was 6 inr.The patient did not remember whether or not internal controls passed while taking these measurements.No error messages occurred.When checking the meter memory, these two values were not present.The last value observed in the meter memory was a value of 2.0 inr measured on (b)(6) 2018.At approximately 12 p.M., the patient tested with the meter and the result was 3.2 inr.No adverse events were alleged to have occurred with the patient.The patient did not report any values from the meter and no actions were taken based on the values.The patient did not receive treatment.The patient's therapeutic range is 2.5 - 3.5 inr.The patient's testing frequency is every two weeks.The patient is not anemic or polycythemic.The patient does not have antiphospholipid antibodies and does not have lupus.The patient does not use heparin or direct thrombin inhibitors.The patient's coumadin dose has not changed since (b)(6) 2018.The patient has had no new medications, no diet changes, and no new illnesses.The patient did not have bleeding or bruising.The patient did not have any special or unusual diet.The meter had not been cleaned recently.The meter appeared clean.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 247896-23) were tested in comparison with the master lot test strips.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.

Manufacturer Narrative

The patient returned the meter and strips for investigation.The patient¿s meter and strips were tested in comparison to a retention meter and master lot strips.Human blood samples from warfarin donors 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, returned meter with returned strips: 2.4 inr.Donor #2: retention meter with master lot strips: 2.9 inr, returned meter with returned strips: 2.7 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned and the retention material meet the specifications.The results were stored in the memory as expected.Upon analysis of the meter memory, the two reported results of 6.0 inr on (b)(6) 2018 are not present.There are two error 6 messages present in the report from (b)(6) 2018.The customer could have incorrectly interpreted the error 6 messages as a result.Error 6 can be caused by movement of the strip during testing.

• 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: 7248621
• MDR Text Key: 99797424
• Report Number: 1823260-2018-00369
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 24789623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Date Manufacturer Received: 01/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM; ARTIFICIAL AORTIC VALVE; ARTIFICIAL KNEES; ATORVASTATIN; CHOLESTYRAMINE LIGHT; COQ10; LEVOTHYROXINE; LISINOPRIL; TRAMADOL; VERAPAMIL; VIT D3; VOLTAREN; WARFARIN/COUMADIN
• Patient Age: 81 YR