MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH ROCHE COAGUCHEK INR METER AND COAGUCHEK XS TEST STRIPS; TEST, TIME, PROTHROMBIN

Lot Number 29415123

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/25/2018

Event Type  malfunction  

Event Description

Pt used roche coaguchek inr point of care machine at home with a result of 4.0.

• Brand Name: ROCHE COAGUCHEK INR METER AND COAGUCHEK XS TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 7914549
• MDR Text Key: 122151622
• Report Number: MW5080172
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2019
• Device Lot Number: 29415123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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 Age: 61 YR
• Patient Weight: 106