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

Model Number 100071

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion: it is indicated that the product is not returning for evaluation.As the patient did not provide a lot number of the product used, testing using reserve product from the same lot and a manufacturing review could not be conducted.No further investigation is possible at this time.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.

Event Description

The patient began using the inratio system in or around 2005 and the inratio2 system in or around 2009.On approximately (b)(6) 2010, the patient recalled receiving a "normal" inratio inr result.The actual result received and the patient's therapeutic range was not provided.On or around (b)(6) 2010, the patient believed she was having a stroke and was admitted to the hospital.During the hospitalization, the patient was diagnosed with a subdural hematoma.No information on laboratory inr testing or treatment provided available.Following the hospitalization, the patient was taken off coumadin, and no longer used the inratio system.No additional information was provided.

Manufacturer Narrative

Additional information: (age at time of the event) was updated to include the patient's date of birth.(describe event or problem) was updated to include the patient's therapeutic range and historical result.(list of products and dates) was updated to include the serial number of the inratio monitor.(reported name and address) was updated to include the email address and address.

Event Description

The patient began using the inratio system in or around 2005 and the inratio2 system in or around 2009.On approximately september 12, 2010, the patient recalled receiving a "normal" inratio inr result.A review of records provided by alere home monitoring indicates the patient received an inr result of 2.8 on (b)(6) 2010.The patient's therapeutic range was 2.0 - 3.0.On or around (b)(6) 2010, the patient believed she was having a stroke and was admitted to the hospital.During the hospitalization, the patient was diagnosed with a subdural hematoma.No information on laboratory inr testing or treatment provided available.Following the hospitalization, the patient was taken off coumadin, and no longer used the inratio system.No additional information was provided.

Manufacturer Narrative

(describe event or problem) updated to include information regarding medical records received 09/15/2017.

Event Description

The patient began using the inratio system in or around 2005 and the inratio2 system in or around 2009.On approximately (b)(6) 2010, the patient recalled receiving a "normal" inratio inr result.The actual result received and the patient's therapeutic range was not provided.On or around (b)(6) 2010, the patient believed she was having a stroke and was admitted to the hospital.During the hospitalization, the patient was diagnosed with a subdural hematoma.No information on laboratory inr testing or treatment provided available.Following the hospitalization, the patient was taken off coumadin, and no longer used the inratio system.No additional information was provided.On 09/15/2017, extensive medical records were received regarding this event.The medical records describe the same event and no new complaint is alleged.There is no reported information that would alter the initial mdr reporting decision or mdr filed.

• 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: 6439877
• MDR Text Key: 71049704
• Report Number: 2027969-2017-00056
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 100071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• 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 MONITOR, PN 200432, SERIAL# UNKNOWN
• Patient Outcome(s): Hospitalization