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

Model Number 100071

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Abdominal Pain (1685); Coagulation Disorder (1779)

Event Date 05/16/2015

Event Type  Injury  

Event Description

The caller alleged a variance between the inratio inr result in comparison to the lab inr result and poc inr result.The caller, wife of the patient self tester, gave the following results; (b)(6) 2015: inratio=2.5; 6/9/15 lab=6.85 - testing was performed 24 days apart.(b)(6) 2015 (6:36am) inratio=3.9, (12:15pm) other poc monitor inr=6.0.Patient self tester's therapeutic range is: 2.5-3.0.Wife noted that the patient tests monthly.On (b)(6) 2015 the patient was not feeling well and was experiencing abdominal pain.At the er his lab inr=6.85.Patient was not admitted but microscopic traces of blood were found in his urine which led the doctor to consider kidneys stone.However, a cat scan showed no kidney stones visible.Patient was believed to possibly have an ulcer and was sent home with some liquid medication to numb the pain.He is to follow up with a specialist.Doctor did not treat the patient to lower his inr but had the patient hold his anticoagulant for two days.Patient followed up with his doctor in two days.His inratio=3.9 and doctor's poc inr=6.0.Patient was told to hold his anticoagulant for four days.Caller is patient's wife, (b)(6), and she stated that it is typical that multiple drops are needed and that the finger touches the strip during application.She could not recall if this was the instance in both cases, but she stated that it very well could have been.

Manufacturer Narrative

Investigation pending.

Manufacturer Narrative

The customer did not provide a lot number or return any products for investigation.Since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.Trending of this issue will be performed.

• Brand Name: INRATIO PT/INR TEST STRIPS
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4893038
• MDR Text Key: 6831091
• Report Number: 2027969-2015-00474
• 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,Distributor,consumer,distributor
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/12/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 07/06/2015
• 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: CYMBALTA; PROTONIX; COUMADIN
• Patient Outcome(s): Required Intervention