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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hematoma (1884); Weakness (2145); Patient Problem/Medical Problem (2688)

Event Date 08/15/2018

Event Type  Injury  

Event Description

Inaccurate test strips causing hospitalization for sub-dural hematoma on (b)(6) 2018, diagnosed in july, resulting in extended hosp stay, craniotomy, icu stay and a stay in a rehabilitation facility lasting 5 weeks.Subsequent physical therapy, possible speech therapy, left side weakness, currently unk if weakness will persist after therapy.

• Brand Name: COAGUCHEK TEST STRIPS
• Type of Device: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS OPERATIONS, INC.
• MDR Report Key: 8090726
• MDR Text Key: 128065316
• Report Number: MW5081508
• 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: 11/16/2018

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2018
• 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: 71 YR
• Patient Weight: 100