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 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of discrepant inr results on coaguchek xs meter serial number (b)(4).The customer tested initially at 9:34 a.M.With a result of 3.1 inr.The customer re-tested 3 more times at 9:36 a.M., 9:48 a.M.And 9:51 a.M.With results of 3.2 inr, 4.2 inr and 3.4 inr respectively.No results were reported to the customer's doctor.The customer used a different finger for each test.The customer's therapeutic range is 2.5 ¿ 3.5 inr.No treatment was necessary.No adverse event occurred.The customer is feeling fine.The customer thinks the result of 4.2 inr may be correct and may reduce his warfarin dose.The customer has no hct issues.The customer is not on heparin or other direct thrombin inhibitors.The customer does not have antiphospholipid antibodies.The customer is not on any new medications.The customer's vegetable intake is different from week to week.The customer has had no recent illnesses and no symptoms of bleeding or bruising.The meter and test strips were requested for return.

Manufacturer Narrative

Relevant retention test strips (lot 235476-11) 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 customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

• 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: 7345854
• MDR Text Key: 103160194
• Report Number: 1823260-2018-00869
• 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: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 04625374160
• Device Lot Number: 23547611
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL; AMIODARONE; ASPIRIN; BUMETANIDE; CARVEDILOL; ENTRESTO; LEVOTHYROXINE; LINZESS; NEUPRO; SIMVASTATIN; WARFARIN
• Patient Age: 58 YR
• Patient Weight: 75