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

Model Number 99008G1

Device Problems Nonstandard Device (1420); Incorrect Or Inadequate Test Results (2456)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Report received of discrepant inratio values.Event occurred in (b)(6).The wife of the patient called due to the voluntary withdrawal of the inratio.Patient's therapeutic range 2 - 3.It was reported the patient has not used the inratio product for over a year.At the beginning of 2015 (exact date not available), the patient had several cases of discrepant results (inr/inr).There are no results or documentation available.Reportedly, the patient was hospitalized due to bleedings (nose, mouth, shoulder).The hospital obtained a higher result than the inratio inr results (no results or documentation available).The patient also reported about a macumar intolerance.No additional information provided.

Manufacturer Narrative

Correction: further investigation revealed that the country of occurrence of the incident reported on (b)(6) 2016 was actually (b)(6).A new mdr #2027969-2016-00713 was submitted to cover the event.

• 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: 6214175
• MDR Text Key: 63588700
• Report Number: 2027969-2016-00709
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• 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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 99008G1
• 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
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z2354-2016 Z2362-2016
• Patient Sequence Number: 1
• Treatment: INRATIO2 HOME USE METER PACK SERIAL #(B)(4)
• Patient Outcome(s): Hospitalization; Required Intervention