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

Model Number 100071

Device Problem Low Test Results (2458)

Patient Problems Bruise/Contusion (1754); Fall (1848); Swelling (2091)

Event Date 12/08/2014

Event Type  Injury  

Event Description

Caller alleged discrepant inratio results.Results as follows: date inratio lab (b)(6) 2014 2.7 4.9 time between tests: 3 hours therapeutic range: 2.0-3.0 the patient self tester went to the er on (b)(6) 2014 due to a bruise on the left leg that was caused from a fall 2 prior.At the time of fall, the patient did not go to the hospital.When the leg began to bruise and swell up, the patient went to the er.Before going to the er, the patient performed an inratio test receiving (inr= 2.7).At the time of admission to the er, the patients inr was checked (lab= 4.9).The customer no longer has the strip lot number that was used.As of (b)(6) 2014, the patients coumadin dose was held.No other treatments were provided.The patient was discharged the same day, and is at home and doing well.

Manufacturer Narrative

Further investigation cannot be pursued because no strip lot number was reported and no product is expected to return.This issue will be subject to future tracking.Corrective action is not required at this time.

• 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 CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4404130
• MDR Text Key: 5433207
• Report Number: 2027969-2015-00009
• 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: Consumer,Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/10/2014

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: 100071
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/09/2015
• 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: COUMADIN,HIGH BLOOD PRESSURE AND CHOLESTEROL MEDS.; INRATIO MONITOR SERIAL #(B)(4)
• Patient Outcome(s): Required Intervention