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

Lot Number 27216700-334498

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 10/25/2018

Event Type  malfunction  

Event Description

Notified on (b)(6) 2018 by roche diagnostics of "urgent medical device correction", instructed for coaguchek xs pt test strip (b)(4) through (b)(4) if inr >4.5 to obtain venipuncture.Nursing visit on (b)(6) 2018 to obtain inr via coaguchek xs pt test strip with range as above.Inr was 7.4, physician notified, venipuncture obtained, inr: 4.8.Diagnosis or reason for use: coumadin therapy.

• Brand Name: COAGUCHEK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; indianapolis IN 46250
• MDR Report Key: 8046438
• MDR Text Key: 126963960
• Report Number: MW5081131
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 27216700-334498
• Was Device Available for Evaluation?: No
• 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: 65 YR
• Patient Weight: 67