MAUDE Adverse Event Report: ROCHE DIAGNOSTICS OPERATIONS, INC. COAGUCHEK TEST STRIPS; TEST, TIME, PROTHROMBIN

Catalog Number 04625374160

Device Problem High Readings (2459)

Patient Problems Fall (1848); Head Injury (1879)

Event Type  Injury  

Event Description

Spring to fall of 2018, i could not get my inr in range - tested weekly with very high reading.Fell and hit my head, had mri because of high inr readings.Coaguchek xs pt test strip - determined to be faulty.

• Brand Name: COAGUCHEK TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC. ; indianapolis IN
• MDR Report Key: 8133573
• MDR Text Key: 129574480
• Report Number: MW5081838
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 04625374160
• Device Lot Number: 28124121-33449723
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2018
• 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): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 95