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

Model Number 317

Device Problem Nonstandard Device (1420)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/09/2019

Event Type  Injury  

Event Description

We were never informed of your recall of test strips for roche coagucheck test strips.Significant other ended up in emergency room for internal bleeding, 4 pints of blood added.They know we have the matching yet failed to notify us.Granted she fell out of their "system" and has been getting strips elsewhere, but i feel they have a moral obligation to send out notifications to anyone with the meter.Now they won't replace the defective ones.What are my options? fda safety report id# (b)(4).

• Brand Name: COAGUCHECK XS TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8939889
• MDR Text Key: 156087454
• Report Number: MW5089389
• 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
• Type of Report: Initial
• Report Date: 08/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 317
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 73 YR
• Patient Weight: 73