MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH COAGUCHEK XS 24 TESTS USA; TEST, TIME, PROTHROMBIN

Model Number UP1270446

Device Problems Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Stroke/CVA (1770)

Event Date 11/17/2018

Event Type  Injury  

Event Description

My inr machine test strips were recalled while i had a stroke with inaccurate test results.

• Brand Name: COAGUCHEK XS 24 TESTS USA
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH
• MDR Report Key: 8227780
• MDR Text Key: 132624816
• Report Number: MW5082916
• 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: 01/03/2019

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: Lay User/Patient
• Device Model Number: UP1270446
• Device Catalogue Number: 03666794
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 48 YR
• Patient Weight: 92