FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 2119497 · Received May 4, 2011

Report

Report Number: 2027969-2011-00984
Event Type: Malfunction
Date Received: May 4, 2011
Date of Event: April 7, 2011
Report Date: May 4, 2011
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: CO, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 4.6, REFERENCE: 2.5, MEAN: 3.55, CONFIDENCE LIMITS: 2.0-5.0. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID MEET ACCURACY CRITERIA. CUSTOMER'S RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. NO FURTHER INVESTIGATION REQUIRED. AS REVIEWED ON (B)(6) 2011, NINETY-EIGHT DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #241836, YIELDING A COMPLAINT RATE OF 0.104%. ACTION THRESHOLD HAS BEEN REACHED. SINCE RELEASE OF STRIP LOT, SIX IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED ON RETAINED AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE TESTS. TEST RECORDS INDICATED THAT ALL STRIP TEST RESULTS MET PRODUCT PERFORMANCE WHEN COMPARED TO THE RESULTS FROM IN VIVO TESTS. 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 DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO: 4.6, LAB: 2.5. PATIENT'S THERAPEUTIC RANGE: 3.5-4.0 INR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC	100071	241836

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI