MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHECK XS CAT/TYP: 03666794; TEST, TIME, PROTHROMBIN

Model Number 03666794

Device Problems Nonstandard Device (1420); High Test Results (2457)

Patient Problems Pulmonary Embolism (1498); Thrombus (2101)

Event Date 11/04/2018

Event Type  Injury  

Event Description

We do home test inr with a coaguchek xs by roche.The test strips were recalled due to faulty calibration.My father ended up with a pulmonary embolism and clots in his legs.We believe that it was a direct result of the meter testing too high.The hospital took him off warfarin and put him on the injectable blood thinner lovenox.Meter type: (b)(4), bad strips: lot number 29778721, exp 09/30/2019.He was hospitalized for six days (b)(6) 2018 to (b)(6) 2018.He then went to a rehab nursing home until (b)(6) 2018.We are now struggling to get back on warfarin.We do have new strips from roche.

• Brand Name: COAGUCHECK XS CAT/TYP: 03666794
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8124668
• MDR Text Key: 129307328
• Report Number: MW5081761
• 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: 11/29/2018

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: Other
• Device Expiration Date: 09/30/2019
• Device Model Number: 03666794
• Device Lot Number: 29778721
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 90 YR
• Patient Weight: 87