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

Model Number 100071

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problems Misdiagnosis (2159); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: further investigation cannot be pursued because there is no lot number/serial number and product was not returned.

Event Description

Report received of discrepant inratio value.Patient's therapeutic range unknown.Patient self tester's husband called with the following details: patient self tester was in a lot of pain and both sides of her body turned black with bruises.Patient was taken to the hospital (unknown date) where her inr was measured at 8.4.The patient had tested a few days prior to this hospitalization on the inratio meter (unknown date) and obtained an inratio inr result of 2.1.Patient was admitted to valley hospital for five days where she was taken off of coumadin and given vitamin k injections.Patient was later transported to a rehab facility where she stayed for three weeks and was sent home around (b)(6) 2016.Since being discharged, a home health nurse had been coming to patient's home.Patient's husband said patient will have to be re-admitted into the rehab facility for further treatment.No additional information provided.

Manufacturer Narrative

Additional information was received by the manufacturer regarding the reported events.Event (describe event or problem) and other relevant history (other relevant history, including preexisting medical conditions) were updated to reflect this information.

Event Description

The patient began using the inratio system in approximately 2013 and tested weekly.On or around august 2016, the patient experienced a significant amount of pain and both sides of her body turned black with bruises.The patient was reported as having been falling more frequently.The patient was taken to the emergency department with back pain and multiple falls.At the emergency room, the patient's inr was measured at 8.4.The patient had tested a few days prior to hospitalization using the inratio meter and obtained an inr result of 2.1.The patient was diagnosed with warfarin toxicity and frequent falls and was hospitalized for five days while she was taken off of coumadin and given vitamin k injections.The patient was later transported to a rehab facility where she stayed for three weeks and was sent home around 09/06/2016.After being discharged, a home health nurse made visits to the patient's home.According to the patient's husband, the patient would need to be readmitted into the rehab facility for further treatment.

• 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
• MDR Report Key: 6054206
• MDR Text Key: 58299341
• Report Number: 2027969-2016-00663
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2354-2016 Z-2362-2016
• Patient Sequence Number: 1
• Treatment: INRATIO MONITOR SERIAL # UNKNOWN; INRATIO MONITOR SERIAL # UNKNOWN
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR