MAUDE Adverse Event Report: ALERE ALERE INRATIO 2 PT/INR STRIPS

Lot Number PN 99008G2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Underdose (2542); Test Result (2695)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

Inr was subtherapeutic using test strips.Diagnosis or reason for use: pulmonary embolism (on warfarin therapy-needs inr checked).Event abated after use stopped or dose reduced: yes.

• Brand Name: ALERE INRATIO 2 PT/INR STRIPS
• Type of Device: PT/INR
• Manufacturer (Section D): ALERE
• MDR Report Key: 3820299
• MDR Text Key: 20017706
• Report Number: MW5036132
• Device Sequence Number: 1
• Product Code: GJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: PN 99008G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRAZAMINE 50 MG AT BEDTIME AS NEEDED; METFORMIN 1000 MG TWICE DAILY; SIMVASTATIN 40 MG DAILY; NOVOLIN R SLIDING SCALE; LANTUS 20 UNITS AT BEDTIME; MOBIC 15 MG DAILY; POTASSIUM CHLORIDE 20 MEQ DAILY; ATENOLOL 25 MG TWICE DAILY; FLOMAX 0.4 MG 1 DAILY FOR KIDNEY STONE; FUROSEMIDE 40 MG DAILY; GABAPENTIN 300 MG TWICE DAILY; ZYRTEC 10 MG DAILY; FLONASE 1 SPRAY DAILY; CYMBALTA 60 MG DAILY; OXYCODONE 10 MG EVERY 4-6 HOURS AS NEEDED; NEXIUM 20 MG DAILY; LISINOPRIL 20 MG DAILY; VENTOLIN AS NEEDED; FLEXERIL 10 MG DAILY; OXYCOTIN 30 MG EVERY 12 HOURS; COUMADIN 15 MG DAILY
• Patient Age: 58 YR
• Patient Weight: 113