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 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient's wife stated that the patient received erroneous results when testing with coaguchek xs meter serial number (b)(4).At 12:08 p.M., a sample from the patient was tested on the meter, resulting as 5.3 inr.At 4:00 p.M., a sample from the patient was tested on the meter, resulting as 5.9 inr.At 4:07 p.M., a sample from the patient was tested on the meter, resulting as 5.8 inr.At 4:12 p.M., a sample from the patient was tested on the meter, resulting as 3.2 inr.The patient did not use alcohol on his finger prior to collecting samples.The patient collects samples from a new finger for each test, but he did mention that he tests for his diabetes as well.No adverse events were alleged to have occurred with the patient.The patient did not receive any treatment or medication changes based on the meter results.The patient's current condition is fine.The patient's therapeutic range is 2.5 - 3.5 inr.The patient's testing frequency is weekly.The patient's wife stated that the patient may be slightly anemic.The patient did not have antiphospholipid antibodies.The patient did not take heparin or direct thrombin inhibitors.The patient did not have any changes in coumadin dose or diet.The patient did not have any special or unusual diet.The patient did not have any new medications or illnesses.The patient did not have any signs of bleeding or bruising.The meter had not been cleaned.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 286319) were tested in comparison with the current 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.

Manufacturer Narrative

The 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: 3.0 inr, donor 2 inr: 2.7 inr.Donor 1 hct: 58%, donor 2 hct: 58%.Testing results: donor 1: retention meter with masterlot strips: 3.0 inr, customer meter with customer strips: 3.1 inr.Donor 2: retention meter with masterlot strips: 2.7 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.

• 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: 7661252
• MDR Text Key: 113504592
• Report Number: 1823260-2018-02194
• 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: 07/13/2018

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: 06/30/2019
• Device Catalogue Number: 04625374160
• Device Lot Number: 28631921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN
• Patient Age: 85 YR