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 Problems Coagulation Disorder (1779); Dizziness (2194)

Event Date 04/14/2014

Event Type  Injury  

Manufacturer Narrative

The customer has not provided any contact information to request the product for return.

Event Description

The customer filed a lawsuit alleging that he received "inaccurate" results on his coaguchek xs meter (serial number was not provided) which caused him to have a stroke.The only information available concerning this incident is from the summons received by roche.The customer did not contact roche with this complaint.Roche has no further information related to this incident other than the following, which was provided in the summons.In 2011, the customer was diagnosed with atrial fibrillation and was prescribed warfarin.In 2011, the customer had his inr tested at the laboratory where the results were sent to his physician who adjusted his warfarin dose as necessary.Around (b)(6) 2014, the customer started using the coaguchek xs meter.The customer used the meter and strips in accordance with their intended use and the instructions given to him by his doctors and the manufacturer.Each time the customer tested his blood, he reported these results to his health care providers.On or around (b)(6) 2014, the customer went to the emergency room due to feeling dizzy and lightheaded.On (b)(6) 2014 the customer had a stroke.It is stated in the summons that the "plaintiff's lightheadedness, dizziness, and stroke occurred because a defect in the meter and/or test strips caused the meter to return significantly inaccurate inr results, which in turn prevented plaintiff's healthcare providers from prescribing a safe and effective dose of warfarin in a timely manner." specific meter results and actions taken based on the meter were not provided.No additional information regarding the patient, treatment provided, and current condition is available.No contact information was provided.No product is expected to be returned for investigation by roche.Within the summons, it is alleged "the meter and test strips were defective and provided inaccurate inr results in many patients, thereby placing users at extreme risk of receiving dangerously incorrect doses of anticoagulants".(b)(6) for the mdr associated with this allegation.

Manufacturer Narrative

A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.Since no customer material was returned, the investigation could not be completed.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5675349
• MDR Text Key: 45751005
• Report Number: 1823260-2016-00682
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 04625374160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other