FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 1873994 · Received October 14, 2010

Report

Report Number: 2027969-2010-01726
Event Type: Malfunction
Date Received: October 14, 2010
Date of Event: September 10, 2010
Report Date: October 14, 2010
Manufacturer: ALERE SAN DIEGO, INC
Product Code: GJS
PMA / PMN Number: 021923
Removal / Correction Number: NI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.4, 2ND INR: 2.3, MEAN: 1.85, SD: 0.64, %CV: 34.40. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT REPEATED INRATIO TEST RESULT COMPARISON DID NOT MEET PRECISION CRITERIA. RETAINED STRIPS WERE TESTED AND RESULTS REVEALED THAT PRECISION CRITERIA WAS MET. DONOR RESULTS WERE 2.94 AND 4.95% CV, RESPECTIVELY AND MEET THE CRITERIA FOR PRECISION. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION WILL BE PURSUED. PATIENT REPORTED HAVING A HARD TIME GETTING A LARGE HANGING DROP OF BLOOD. THIS MAY HAVE AFFECTED INRATIO TEST RESULTS. AS OF 10/14/2010, FIFTEEN DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #234130 YIELDING A COMPLAINT RATE OF 0.013%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%), NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

Description of Event or Problem · 1

CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010; INR: 1.4, 2.3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC	100071	234130

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI