MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS; TEST TIME, PROTHROMBIN

Model Number NOT AVAILABLE

Device Problem Nonstandard Device (1420)

Patient Problems Diarrhea (1811); Hyperplasia (1906); Renal Failure (2041); Thrombosis (2100); Urinary Retention (2119)

Event Date 10/30/2018

Event Type  Injury  

Event Description

Subject is a (b)(6) caucasian male (dob (b)(6)) 2.5 weeks post anterior left hip replacement (surgery date (b)(6) 2018) who was discharged on coumadin.Relevant prior medical history includes, prior right hip replacement; prior right knee replacement, and prior left knee replacement, a fibrillation and prostate hyperplasia.No history of past coagulation disorders.Post surgical course complicated by severe diarrhea and urinary retention, due to prostate hyperplasia resulting in a visit to a primary care physician on (b)(6) 2018.Testing revealed a large deep venous thrombosis (dvt) in his right leg as well as acute renal failure due to obstruction (scr = 6.0).Pt was transferred to (b)(6) hosp for treatment that included heparin and catheter insertion.Subject was transitioned to oral eliquis on (b)(6) 2018 and continues to be monitored.Expected discharge is (b)(6) 2018.On (b)(6) 2018, subject's daughter, after receiving the fda recall notice about the roche diagnostics coaguchek systems, checked with the home care agency responsible for her father's care.They confirmed the use of the coaguchek xs system for their in-home care inr testing.The fda recall notice was shared with this organization who indicated they would take action for further use.

• Brand Name: COAGUCHEK XS
• Type of Device: TEST TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8046237
• MDR Text Key: 126658669
• Report Number: MW5081122
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2018

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: Health Professional
• Device Model Number: NOT AVAILABLE
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 86