FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 2418166 · Received December 12, 2011

Report

Report Number: 2027969-2011-02503
Event Type: Malfunction
Date Received: December 12, 2011
Date of Event: November 17, 2011
Report Date: December 12, 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: AS
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: 5.0, 5.1, REFERENCE: 1.2, MEAN: 3.77, CONFIDENCE LIMITS: 2.2-5.3. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 5.0, 2ND INR: 5.1, MEAN: 5.05, SD: 0.07, %CV: 1.40. ANALYSIS OF CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISON DID NOT MEET ACCURACY CRITERIA. HOWEVER, REPEATED INRATIO TEST RESULT COMPARISON DID MEET PRECISION CRITERIA. CUSTOMER'S RESULTS ARE CONSIDERED DISCREPANT BEYOND THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. NO PRODUCT IS EXPECTED TO BE RETURNED. RETAINED STRIP TESTING PERFORMED ON (B)(4) 2011 REVEALED THAT RESULT COMPARISONS MET ACCURACY CRITERIA. INVESTIGATION RESULTS FOR RETAINED STRIP LOT #253023: AT LEAST TWO OUT OF THREE REPLICATES FOR BOTH DONORS ARE WITHIN THE ALLOWABLE BIAS (+ OR - 1.0) FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. (B)(4). THIS ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. 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: 5.0, 5.1, LAB: 1.2.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	HS0100139	253023

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI