MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625315160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

The customer stated that they received an erroneous result for one patient tested with coaguchek xs meter serial number (b)(4).The customer also stated that an unknown error occurred on the meter on (b)(6) 2018.A display check was performed and no issues were observed.At 1:06 p.M.On (b)(6) 2018 a sample from the patient was tested using the meter, resulting with a value of > 8.0 inr.At 1:20 p.M.On the same date, a sample from the patient was tested in the laboratory using an unknown method, resulting with a value of 5.6 inr.No adverse events were alleged to have occurred with the patient.The patient was not treated and did not have medication changed based on the meter result.The patient is currently in poor condition.The patient's therapeutic range is 2 - 3 inr.The patient's testing frequency is 3 times per week.The patient does not have antiphospholipid antibodies, does not take heparin, does not take direct thrombin inhibitors, had no changes in diet, no illnesses, and no new medications.The patient had no bleeding or bruising.The customer's product was requested for investigation and replacement product was sent to the customer.Relevant retention test strips (lot 345215) were tested in comparison with the master lot.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.

Manufacturer Narrative

The patient's meter and strips were returned for investigation.The returned meter and strips were tested in comparison to master lot strips using quality control material.Testing results: qc 1: 2.4 inr, qc 2: 2.4 inr, qc 3: 2.4 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.(1.9 - 2.9 inr).All measurements were without error messages.The maximum difference between measurements was 0%.

• 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: 8204101
• MDR Text Key: 131772164
• Report Number: 1823260-2018-05172
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

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: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 04625315160
• Device Lot Number: 34521511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN; TRAMADOL
• Patient Age: 63 YR