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 03/21/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient stated that he received erroneous results when testing with coaguchek xs meter serial number (b)(4).Two test strips lot numbers were used for testing, lots 25863822 and 24789623.Patient identifiers for information related to each test strip lot number: pt-22284 = test strip lot number 24789623, pt-22285 = test strip lot number 25863822.At 3:20 p.M., the patient tested a sample on the meter using test strip lot number 24789623 and the result was 4.1 inr.At 3:30 p.M., the patient tested a sample on the meter using test strip lot number 24789623 and the result was 3.1 inr.At 3:40 p.M., the patient tested a sample on the meter using test strip lot number 25863822 and the result was 3.5 inr.The patient mentioned that he collected samples from his little finger for 2 of the tests.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 inr.The patient's testing frequency is every 2 weeks.The patient does not have anemia or antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors.The patient has had no changes in his coumadin dosage or diet.The patient did not have any special or unusual diet.The patient has had no new medications or illnesses.The patient did not have signs of bleeding or bruising.The patient's meter had not been cleaned.The patient did not recall if internal controls on the meter passed.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 current master lot coaguchek xs pt test strip.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 customer's meter was returned for investigation.The returned meter and masterlot strips were tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.0 inr, donor 2 inr: 2.8 inr.Donor 1 hct: 45%, donor 2 hct: 48%.Testing results: donor 1: retention meter with masterlot strips: 2.0 inr, customer meter with masterlot strips: 2.0 inr.Donor 2: retention meter with masterlot strips: 2.8 inr, customer meter with masterlot strips: 2.9 inr.Results: 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 customer stated they used the same finger for two tests.Per package insert, for a second measurement a new puncture of a different finger is mandatory.

• 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: 7400128
• MDR Text Key: 105451620
• Report Number: 1823260-2018-01070
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• 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?: No
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOXETINE; LASIX; TERAZOSIN; TOPAROL; WARFARIN/COUMADIN
• Patient Age: 64 YR