MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME TEST STRIPS

Catalog Number 04625374160

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Coagulation Disorder (1779)

Event Date 10/18/2015

Event Type  Injury  

Manufacturer Narrative

Strips not available for return.

Event Description

The customer using a coaguchek xs (serial number (b)(4)) and he obtained a result of 2.7 inr on (b)(6) 2015 at 7:15 am.On that day he went to the hospital for a bleed on his left leg.He also had pain in the leg that day.His partner drove him to er where he received vitamin k iv and also morphine.He was admitted to hospital overnight and released the next day.No further treatment information was provided and the customer did not know what any of his inr results were at the hospital on the day of admission.He did report the hospital obtained a lab result of 1.1 inr on (b)(6) 2015.Prior to the hospitalization he had obtained a result of 2.9 inr on (b)(6) 2015 on his meter.On (b)(6) 2015, he received results of 1.6 inr on his device.He reported a result of 1.7 inr from his meter on (b)(6) 2015.He was taking plavix at this time and stopped taking it on (b)(6) 2015.The patient also reported that he is not on heparin or taking any direct thrombin inhibitors at this time.He reports no other new medications.He did state he has had possible varied vitamin k vegetables.He is currently feeling better.His therapeutic range was 2.0 to 3.0 inr prior to this event and based on this event it was changed to 1.7 to 2.2 inr.The return of the suspect product was requested, however, he no longer has the vial of strips he used when he obtained the result of 2.7 inr.

Manufacturer Narrative

\relevant retention test strips (lot 20078221) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 230734-80) at roche (b)(4).No error messages occurred.Retention samples were acceptable.

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME TEST STRIPS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5243185
• MDR Text Key: 31937522
• Report Number: 1823260-2015-04618
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 04625374160
• Device Lot Number: 20078221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Home
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 073 YR
• Patient Weight: 70