MAUDE Adverse Event Report: ALERE AN DIEGO, INC. INRATIO PT/INR TEST STRIPS

Model Number 99008G1

Device Problem Low Test Results (2458)

Patient Problem Overdose (1988)

Event Date 08/06/2014

Event Type  Injury  

Event Description

Caller alleged discrepant low inratio2 inr result in comparison to the training center (tc) monitor and laboratory.Testing performed one after the other.Reportedly, patient was provided with an alternate inr monitor by the training center to monitor at home.Patient did not want to go to the er.Patient was administered 5mg of vitamin k.On (b)(6) 2014, additional information provided: patient had a very high overdose of marcumar (phenprocoumon), therefore, did not take marcumar for more than 2 weeks.Patient was treated with konakion.Patient is now doing well, blood count is normal and values are consistent with lab and coagu chek xs.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Manufacturer (Section D): ALERE AN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4098018
• MDR Text Key: 4837753
• Report Number: 2027969-2014-00814
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/08/2014

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: 99008G1
• Device Lot Number: K332845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 09/04/2014
• 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
• Removal/Correction Number: Z-1546-2014
• Patient Sequence Number: 1
• Treatment: COAGU CHEK XS; INRATIO MONITOR, SN: (B)(4)
• Patient Outcome(s): Required Intervention