FDA Adverse Event Malfunction Summary report: N

INRATIO2

MDR report key: 1954257 · Received December 9, 2010

Report

Report Number: 2027969-2010-02138
Event Type: Malfunction
Date Received: December 9, 2010
Date of Event: November 10, 2010
Report Date: December 9, 2010
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K072727
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2010, 1ST INR = 2.0, 2ND INR = 3.7, MEAN = 2.85, SD = 1.20; %CV = 42.18. SINCE % CV IS MORE THAN 20%, THE PRECISION TEST FAILED THE CRITERIA FOR PRECISION. ADDITIONAL INVESTIGATION IS REQUIRED. PREVIOUS INVESTIGATION OF STRIP LOT 237411 ON (B)(6) 2010 MET PRECISION CRITERIA. DATE: (B)(6) 2010, 1ST INR = 2.4, 2ND INR = 2.4, 3RD INR = 2.6, %CV = 4.68. DATE: (B)(6) 2010, IST INR = 2.3, 2ND INR = 2.4, 3RD INR = 2.4, %CV = 2.44. SINCE % CV IS LESS THAT 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. AS REVIEWED ON 12/08/2010, 11 DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #237411 YIELDING A COMPLAINT RATE OF 0.031%. 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:" INR = 2.0, REPEAT INR = 3.7. PATIENT HAD TRAINING LAST WEEK. TRAINER DID TWO TESTS ON HER. FIRST TEST 2.0, REPEATED 3.7. PATIENT DIDN'T REMEMBER IF THE TESTS WERE DONE ON DIFFERENT FINGERS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO2	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	100071	237411

Patients

Seq	Age	Sex	Outcome	Treatment
1