FDA Adverse Event Other Summary report: N

INRATIO

MDR report key: 2121918 · Received April 29, 2011

Report

Report Number: 2027969-2011-00964
Event Type: Other
Date Received: April 29, 2011
Date of Event: April 7, 2011
Report Date: April 29, 2011
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K021923
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

PER ISSUE, CUSTOMER HAS SOME ANEMIA AND A THYROID CONDITION. PATIENT CURRENT HEALTH STATUS MAY LEAD TO UNEXPECTED INR RESULT OR TESTING ERROR. QC ERRORS ARE DESIGNED TO BE GENERATED IF THE STRIP HAS BEEN EXPOSED TO ADVERSE ENVIRONMENTAL CONDITION. THERE IS NO INFORMATION IN THE COMPLAINT TO INDICATE STRIP EXPOSURE. THESE ERRORS ALSO ARISE IF THERE IS A SAMPLING OR TECHNIQUE PROBLEM. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF CORRECTIVE ACTION IS WARRANTED. TWO HUNDRED NINETY SIX DISCREPANT/NON-DISCREPANT RESULTS COMPLAINT WAS REPORTED FOR LOT #241836 YIELDING A COMPLAINT RATE OF 0.315%. ACTION THRESHOLD WAS REACHED. SINCE STRIP LOT RELEASED, 4 IN-HOUSE THERAPEUTIC SAMPLE TESTS AND 1 IN-HOUSE NON-THERAPEUTIC SAMPLE TESTS WERE PERFORMED FOR RETAIN AND RETURNED STRIPS. CUSTOMER'S OBSERVATION HAS NOT BEEN REPRODUCED IN IN-HOUSE 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. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

Description of Event or Problem · 1

PATIENT GOT QC 2H ERROR TWICE. CUSTOMER REPORTS BLEEDING FROM GUMS. TARGET THERAPEUTIC RANGE IS 2.0-3.0.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	100071	246050

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other