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

Device Problem Nonstandard Device (1420)

Patient Problems Myocardial Infarction (1969); Thrombus (2101)

Event Date 10/01/2018

Event Type  Injury  

Event Description

My (b)(6) son had a nstemi related to a clot.He has a mechanical aortic valve using coaguchek xs pt test strips to monitor his inr, that now have been recalled.Thirteen days in the hospital and countless procedures.

• Brand Name: COAGUCHECK XS PT TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8074723
• MDR Text Key: 127528676
• Report Number: MW5081313
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/10/2018

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2018
• 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: 16 YR
• Patient Weight: 68