INRATIO

MDR report key: 1971379 · Received January 11, 2011

Report

Report Number: 2027969-2011-00077
Event Type: Injury
Date Received: January 11, 2011
Date of Event: December 20, 2010
Report Date: January 11, 2011
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K021923
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION PENDING.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INRATIO: 3.5; LAB: 6.6 ((B)(6) 2010). METER READING WAS TAKEN ON (B)(6) 2010, AND THE LAB DRAW WAS DONE ON (B)(6) 2010. PT IS ON EXPERIMENTAL CHEMO-THERAPY. HUSBAND HAS BEEN DOING HER INRATIO AT HOME. HUSBAND IS COUMADIN DOSING WIFE ON HIS OWN WITHOUT DOCTORS RECOMMENDATIONS. PT HAD A 30% OR OCCASIONALLY <30% HEMATOCRIT. THERE ARE SIDE EFFECTS FROM THE CHEMO THAT WILL AFFECT COAGULATION FACTORS. PT HAS A PORT TO DRAW BLOOD THAT IS RINSED WITH HEPARIN. CARDIOLOGIST IS NOT MONITORING PT BECAUSE OF HUSBAND DOSING THE WIFE AS HE SEEMS NECESSARY. PT INR MUST BE WITHIN 2-3 IN ORDER FOR HER TO RECEIVE HER NEXT CHEMO TREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	100139	NG

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other