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

Catalog Number 04625374160

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation - the occupation is lay user/patient.

Event Description

The patient stated that she received an erroneous result when testing with coaguchek xs meter serial number (b)(4).At 1:02 p.M., a sample from the patient was tested using the meter, resulting with a value of 3.6 inr.At 1:05 p.M., a sample from the patient was tested in the laboratory using an unknown method, resulting with a value of 2.5 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 value.The patient is currently stable and well.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is monthly if the result are within therapeutic range and once every two weeks if outside of range.The patient did not have antiphospholipid antibodies or issues with hematocrit levels.The patient did not take heparin or direct thrombin inhibitors.The patient was not taking any new medications, did not have any changes in diet, no illnesses, and did not have abnormal bleeding or bruising.The patient did not have a special or unusual diet.The meter heater plate was not clean as it had two brown dots on it.Changes were made to the patient's dosage based on a meter result of 3.4 inr obtained on (b)(6) 2018.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 353497) 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 was returned for investigation and was tested with qc material in combination with master lot strips.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%.

Manufacturer Narrative

Coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.

• 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: 8203891
• MDR Text Key: 131772455
• Report Number: 1823260-2018-05168
• 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,Followup
• Report Date: 04/11/2019

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: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 04625374160
• Device Lot Number: 35349723
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/17/2018; 12/17/2018
• Supplement Dates FDA Received: 01/16/2019; 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARVEDILOL; FLECAINIDE; LOSARTAN; SPIRONOLACTONE; WARFARIN
• Patient Age: 77 YR
• Patient Weight: 102