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 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The patient's son stated they received questionable results from coaguchek xs meter serial number (b)(4).They used strip lots 27216421 and 25863822 on both dates of testing.He could not specify which lot gave which results.The medwatchs involved in this event include patient identifiers (b)(6).On (b)(6) 2018, within 30 minutes the results from two different fingers were 2.3 inr, >8.0 inr, and 1.6 inr.He stated the patient ate some brussel sprouts in between the tests.No changes were made in the warfarin dose due to the results.On (b)(6) 2018, the patient performed three tests within less than 10 minutes and the results were 2.3 inr, 1.8 inr and 1.9 inr.The patient's son reported the result of 2.3 inr.There was no allegation of an adverse event.There were no recent changes in health or other medications, no other blood thinners except warfarin and baby aspirin.The patient had no direct thrombin inhibitors, no lupus, no antiphospholipid antibodies, and no concerns with hematocrit levels.The patient had no signs of high inr.The therapeutic range was 2.0-3.0 inr.The suspect meter and strips were requested to be returned for investigation.Relevant retention test strips (lot 272164) were tested in comparison with the master lot coaguchek xs pt.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable and retention material performed as specified.

Manufacturer Narrative

The customer meter and strips were returned for investigation.The returned meter and strips were tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.4 inr, donor 2 inr: 2.8 inr.Donor 1 hct: 47%, donor 2 hct: 38%.Testing results: donor 1: retention meter with masterlot strips: 2.4 inr, customer meter with customer strips: 2.4 inr.Donor 2: retention meter with masterlot strips: 2.8 inr, customer meter with customer 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.Customer stated that they not always apply the sample within 15 seconds.Per product labeling blood should be applied within 15 seconds of the fingerstick.The results alleged by the customer were observed in the meter¿s patient result memory.

• 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: 7479349
• MDR Text Key: 107825936
• Report Number: 1823260-2018-01320
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 27216421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "BLOOD PRESSURE PILLS"; "CHOLESTEROL PILLS"; "WATER PILLS"; ASPIRIN; WARFARIN
• Patient Age: 82 YR
• Patient Weight: 73