FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 1853382 · Received September 27, 2010

Report

Report Number: 2027969-2010-01511
Event Type: Malfunction
Date Received: September 27, 2010
Date of Event: August 25, 2010
Report Date: September 20, 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: NY, 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: 1.5, REFERENCE: 2.6, MEAN: 2.05, CONFIDENCE LIMITS: 1.4-3.1. INRATIO: 3.0, REFERENCE: 2.6, MEAN: 2.80, CONFIDENCE LIMITS: 1.4-3.1. INRATIO PRECISION DATA PROVIDED BY END-USER: 1ST INR: 1.5, 2ND INR: 3.0, MEAN: 2.25, SD: 1.06, %CV: 47.14. THE 2.3 INR WAS EXCLUDED FROM COMPARISON TEST SINCE THERE WAS NO CORRESPONDING REFERENCE INR RESULT FOR DATA ANALYSIS. ANALYSIS OF THE CUSTOMER'S DATA REVEALED THAT INRATIO AND REFERENCE TEST RESULT COMPARISONS DID NOT MEET PRECISION CRITERIA, BUT DID MEET ACCURACY CRITERIA. NO PRODUCT INFORMATION WAS AVAILABLE. NO PRODUCT IS EXPECTED TO BE RETURNED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. 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: NG, INRATIO: 2.3, LAB: NG. DATE: (B)(6) 2010, INRATIO: 1.5, LAB: 2.6. DATE: , INRATIO: 3.0, LAB: 2.6. CALLER ALSO ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: DATE: (B)(6) 2010, INR: 1.5. DATE: , INR: 3.0.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI