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

Model Number 99008G1

Device Problem Low Test Results (2458)

Patient Problem Coagulation Disorder (1779)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.The patient was unable to provide the lot number of the product used.A review of manufacturing records and testing using reserve product could not be conducted as no lot number is available.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The patient reported receiving inratio inr results within the therapeutic range of 2.0-3.0 while on vacation in (b)(6) in 2015.During this vacation, the patient was taken to the hospital for bleeding from nose, mouth, and shoulder.The patient's inr was tested using a laboratory method and the result was "way higher" than the therapeutic range.No information regarding treatment or intervention was provided.The patient discontinued use of phenprocoumon and the inratio inr system.No additional information is available.

• 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 Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6214665
• MDR Text Key: 63606711
• Report Number: 2027969-2016-00713
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2016

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 99008G1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 12/29/2016
• 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: INRATIO2 PT MONITOR, PN 200433, SERIAL# (B)(4)
• Patient Outcome(s): Hospitalization; Other