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

Model Number 99008G2

Device Problems Improper or Incorrect Procedure or Method (2017); Low Test Results (2458)

Patient Problems Death (1802); Hemoptysis (1887); Low Blood Pressure/ Hypotension (1914); Overdose (1988)

Event Date 01/20/2014

Event Type  Death  

Event Description

Caller alleged discrepant low inratio inr result in comparison to the laboratory result.Pt is a (b)(6) old male who was recently hospitalized on (b)(6) 2014 for effusion and lung mass and diagnosed with metastatic small cell lung carcinoma.On (b)(6) 2014 at 5:15pm, the pt's inratio inr result was 2.8 and warfarin 3mg was administered.Reportedly, the finger was "milked" after the finger stick and the sample was not immediately applied.The pt's therapeutic was 2.0 - 3.0.At 8:15pm, the pt experienced what was described as "massive hemoptysis".The pt was intubated while en route to the emergency room.The laboratory inr at 10:40pm was 7.6, hemoglobin = 12.2 and hematocrit = 37.5 (prior to blood transfusion).The pt was hospitalized on a ventilator in icu, administered vitamin k, 3 units of fresh frozen plasma (ffp), 2 units of blood, antibiotics and pressors as needed for hypotension.Ct scan of the brain revealed no acute changes.Ct scan of the chest revealed no pulmonary embolism (pe) but lung mass and possible bilateral process.After pt treatment, the laboratory inr was 1.8.On (b)(6) 2014 due to the pt's poor prognosis, terminal cancer and his wishes to not have to go through further invasive medical care, the pt was placed on a morphine drip and the pressors (propofol) was discontinued.The pt's aicd was turned to "no shock", the pt was extubated and expired at 6:47 pm.No additional information was provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: INRATIO PT/INR TEST STRIP
• Type of Device: PROTHROMBIN TIME TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3678573
• MDR Text Key: 4261904
• Report Number: 2027969-2014-00135
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2014

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: Health Professional
• Device Model Number: 99008G2
• Device Lot Number: 324810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/19/2014
• 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
• Patient Sequence Number: 1
• Treatment: AMIODARONE HCL 200MG DAILY; ASPIRIN 81MG DAILY; INRATIO 2 PT/INR PRO MONITOR SN (B)(4) WARFARIN; COREG 6.25MG TWICE A DAY; LASIX 60MG DAILY DATE OF TX (B)(6) 2014; LANOXIN 0.125MG DAILY; CAPTOPRIL 6.25MG TWICE A DAY
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 67 YR