MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH / ROCHE DIAGNOSTICS OPERATIONS, INC. COAGUCHEK INR MACHINE; CALCULATOR / DATA PROCESSING MODULE, FOR CLINICAL USE

Device Problem Low Readings (2460)

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

Event Date 07/18/2019

Event Type  Injury  

Event Description

Product coagucheck inr machine, error is that the machine read a therapeutic inr of 2-3, however, a venipuncture taken within 3 hours showed an inr of 1.9.Fda safety report id# (b)(4).

• Brand Name: COAGUCHEK INR MACHINE
• Type of Device: CALCULATOR / DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH / ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8822263
• MDR Text Key: 152193057
• Report Number: MW5088327
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2019
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 127