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 Consequences Or Impact To Patient (2199)

Event Date 06/12/2018

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).The patient also received an error when testing on the meter.At 9:17 a.M., a sample from the patient was tested on the meter, resulting as 3.4 inr.At 9:21 a.M., a sample from the patient was tested on the meter, resulting as 3.8 inr.At 9:43 a.M., a sample from the patient was tested on the meter, resulting as 2.3 inr.The patient stated that his blood was runny when testing.The patient stated that he collects enough blood when dosing the test strips.No adverse events were alleged to have occurred with the patient.The patient's coumadin dose was lowered based on the meter results.The patient is in stable condition.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is every two weeks.The patent stated that his fingers were a little damp prior to collecting a sample.The patient is not anemic and does not have antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors.The patient does not take any new medications or have any recent illnesses.The patient has been eating beets and black olives.The patient's doctor advised the patient that the beets and black olives would interfere with his inr.The patient has a bruise, but did not seek medical treatment.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 250322) 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.No error messages occurred.Retention samples were acceptable.Upon review of the meter memory, the following discrepancies were also observed: on (b)(6) 2017 at 08:55, the patient had a result of 3.3 inr.On (b)(6) 2017 at 09:00, the patient had a result of 2.5 inr.

Manufacturer Narrative

The patient meter was returned for investigation.The returned meter was tested in comparison to a retention meter and masterlot strips.Human blood samples from warfarin donors were used.Donor 1 inr: 2.7 inr, donor 2 inr: 2.2 inr.Donor 1 hct: 38%, donor 2 hct: 48%.Testing results: donor 1: retention meter with masterlot strips: 2.7 inr, customer meter with masterlot strips: 2.7 inr.Donor 2: retention meter with masterlot strips: 2.2 inr, customer meter with masterlot strips: 2.2 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.Customer stated the finger was damp when it was stuck.Residues of water or disinfectant on the skin can dilute the drop of blood and lead to incorrect results.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: 7649661
• MDR Text Key: 113020562
• Report Number: 1823260-2018-02097
• 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: 06/29/2018

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: 02/28/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 25032221
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/12/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN; ATORVASTATIN; COUMADIN; DIGOXIN; DOXAZOSIN; FINASTERIDE; LISINOPRIL; MESYLATE; METOPROLOL; SUCCANATE
• Patient Age: 78 YR
• Patient Weight: 108