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 Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient's daughter stated that the patient received erroneous when testing with coaguchek xs meter serial number (b)(4).At 1:18 p.M., a sample from the patient was tested on the meter, resulting as > 8.0 inr.The patient reported this value to her doctor and she was advised to repeat testing.At 2:45 p.M., a sample from the patient was tested on the meter, resulting as 3.8 inr.No adverse events were alleged as related to the meter results.The patient's therapeutic range was asked for, but not provided.The patient is not anemic.The patient does not have antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors.The patient has had no changes in coumadin dosage and no new medications.The patient has had no changes in diet and no recent illnesses.The patient's daughter did not see the patient perform testing, but believes that a sample from the patient's finger was applied to the test strip within 15 seconds.The patient's daughter did not know if the patient used the same finger when performing repeat testing.The patient's product was requested for investigation and replacement product was sent to the patient.The test strip vial was thrown away, so it will not be available for return.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

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: 7248761
• MDR Text Key: 99799796
• Report Number: 1823260-2018-00364
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN
• Patient Age: 88 YR