MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SYSTEM

Model Number 04837975001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

Event Description

Nurse (b)(6) checked patient's pt/inr using coaguchek xs machine and obtained an inr reading of 4.1.She called md who ordered her to check inr result using coaguchek machine: 4.1.Inr result using venipuncture: 2.9.Both were performed on (b)(6) 2018.Patient is also taking amiodarone which may impact pt/inr results.Check pt/inr using venipuncture.Rn performed venipuncture and took the vial to alexian brothers hospital laboratory.The results were faxed at 5:25 pm and the inr was 2.9.Md was notified and he decreased the warfarin dose to 4mg.The coaguchek machine was returned to the manufacturer on (b)(6) 2018.

• Brand Name: COAGUCHEK XS SYSTEM
• Type of Device: COAGUCHEK XS SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; indianapolis IN
• MDR Report Key: 7237849
• MDR Text Key: 99009028
• Report Number: MW5075031
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04837975001
• Device Lot Number: UP0767456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 113