FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 2022512 · Received February 15, 2011

Report

Report Number: 2027969-2011-00322
Event Type: Malfunction
Date Received: February 15, 2011
Date of Event: January 20, 2011
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K021923
Removal / Correction Number: NI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

NO DATA ANALYSIS WAS PERFORMED BECAUSE TIME BETWEEN TESTS EXCEEDED THREE HOURS. SINCE TIME BETWEEN TESTS EXCEEDED THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGES IN THE STATUS OF THE PT. THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. PREVIOUS INVESTIGATION OF STRIP LOT 233708 FROM (B)(6) 2011 MET PRECISION CRITERIA. DATE: (B)(6) 2011; DONOR: 1, 1ST INR: 2.9, 2ND INR: 2.9, 3RD INR: 3.0, MEAN: 2.93, SD: 0.06, %CV: 1.97; DONOR: 2, 1ST INR: 2.1, 2ND INR: 2.1, 3RD INR: 2.1, MEAN: 2.1, SD: 0.00, %CV: 0.00. SINCE % CV IS LESS THAN 20%, THE RESULTS FOR INRATIO METER PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. (B)(4). ACTION THRESHOLD HAS BEEN REACHED. SINCE STRIP LOT RELEASED, IN-HOUSE THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN TEST. TEST RECORDS INDICATED 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.

Description of Event or Problem · 1

CALLER ALLEGED IMPRECISION WITH INRATIO METER. PT CONFIRMED HAD THE METER FOR FIVE YEARS AND NEVER HAD ISSUE BEFORE. PT CONFIRMED HAD NO CHANGE IN DIET OR MEDICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	100071	233708

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI