FDA Adverse Event Malfunction Summary report: N

INRATIO2 PT/INR PROFESSIONAL TEST STRIP

MDR report key: 3874359 · Received April 21, 2014

Report

Report Number: 2027969-2014-00360
Event Type: Malfunction
Date Received: April 21, 2014
Date of Event: March 24, 2014
Report Date: March 31, 2014
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K110212
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INRATIO 2 PT/INR PROFESSIONAL TEST STRIP LOT #312525 REFERENCED, IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER 2027969-2014-00361. INVESTIGATION PENDING.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT LOW INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO2 MONITOR SN (B)(4), STRIP LOT 312525: INR=3.0; INRATIO2 MONITOR SN (B)(4), STRIP LOT 333655: INR=6.7; LABORATORY INR: 11.0; THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN THE INRATIO2 TESTING WAS FIVE (5) MINUTES AND THE TIME BETWEEN THE INRATIO2 TESTING AND THE LABORATORY TESTING WAS NINE (9) HOURS. REPORTEDLY, THE MONITOR WAS NOT IN THE CORRECT MODE WHEN THE FINGER STICK WAS PERFORMED AND THE FINGER WAS MILKED AFTER THE FINGER STICK. ADDITIONALLY, THE CUSTOMER WAS USING MICROSAFE TUBES. THE PATIENT WAS ORDERED BEDREST UNTIL INR RETURNED TO THERAPEUTIC RANGE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
241010	INRATIO2 PT/INR PROFESSIONAL TEST STRIP	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	99008G2	333655

Patients

Seq	Age	Sex	Outcome	Treatment
1				WARFARIN\| INRATIO2 PT/INR MONITOR, SN (B)(4)\| INRATIO2 STRIP LOT 312525\| INRATIO2 PT/INR MONITOR, SN (B)(4)