MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST

Model Number 100071

Device Problem Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Death (1802); Headache (1880); Hematoma (1884)

Event Date 12/11/2014

Event Type  Death  

Event Description

On (b)(6) 2015, notification was received from the department of health & human services, food and drug administration (fda) that a user facility form (mw5039730) was submitted by the physician.The following is a description of what was reported by the physician: "home inr monitor registered 2.1.Patient developed bruising, headache, died in bed, autopsy showed large subdural hematoma.The inr manufacturer issued recall immediately after." the physician was contacted but would not release any information without permission of the patient's family.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of death.Based on the inability to rule out the possibility that the device may have caused or contributed to the death, this event is conservatively reported as a death based on the autopsy showing a large subdural hematoma being potentially related to the patient's coagulation status; however, a device deficiency cannot be substantiated.

Manufacturer Narrative

Investigation/conclusion: since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.There is no information available to suggest a malfunction or that the device caused or contributed to the reported event.The patient's coagulation status was unknown at the time of death.Based on the inability to rule out the possibility that the device may have caused or contributed to the death, this event is conservatively reported as a death based on the autopsy showing a large subdural hematoma being potentially related to the patient's coagulation status; however, a device deficiency cannot be substantiated.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4835841
• MDR Text Key: 5911306
• Report Number: 2027969-2015-00377
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2015

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: 100071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: WELLBUTRIN; INRATIO MONITOR SN UNKNOWN
• Patient Outcome(s): Death